FDA Refuses to Approve Original Versions of OxyContin for Sale in the U.S.

OxyContin released a new formulation of the controversial drug that the FDA is now approving as the only type allowed in the U.S.

Who is selling counterfeit surgical mesh for hernia and chest wall repairs?

Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name. These meshes, specifically identified below, are NOT Bard-manufactured products. Surgical meshes of this kind are used to reinforce soft tissue where weakness exists in the repair of hernias and chest wall defects.

Recall of AED 10 and MRL JumpStart external defibrillators

If your business owns a defibrillator take a look to see if it’s a “14,054 AED 10 and MRL JumpStart external defibrillators made between Oct. 3, 2002, and Jan. 25, 2007. They may not work correctly when called upon to shock a patient resulting in low-energy shocks. There have been 39 incidents reported resulting in two deaths. The company, Welch Allyn and the U.S. Food and Drug Administration are having a recall of this model.  On the Welch Allyn website they provide a way for you to check the serial numbers on the unit you own to know if it’s affected by the recall.  

This is really a tough business we are in as litigators. Yeah I know no one wants to listen to a personal injury lawyer whine. But really it is. Think about this situation for a moment. You expect a defibrillator to work properly when you suffer a heart event requiring it’s use. And when it doesn’t and it’s predictable due to a defect in the equipment you expect the lawyer to sue the company. But the client may be dead due to what? Was it due to the defibrillator not working right or the heart event?

What came first the chicken or the egg? Well I guess it will all come down to the autopsy and what the medical examiner says was the actual heart event and how easily that condition is normally corrected. Follow the FDA link for further information.

Welch Allyn currently sells at least five different model defibrillators. The AED 10 is described below:

AED 10™ Defibrillator

Designed for easy operation and quick deployment by the infrequent user, the AED 10 is a simple, proven solution for quick and easy response to cardiac emergencies.

·                          Text and voice instructions guide the user through the rescue

·                          Color-coded pads and illustrations ensure proper pad placement

·                          Escalating energy (200 J, 300 J, 360 J); energy protocol can be changed to meet specific needs

·                          High-performance battery delivers up to 90 discharges at 360 joules

·                          Internal memory stores event data including ECG waveforms, time/date stamps, shock delivery and system actions

·                          Lightweight and compact—ideal for small spaces

FDA announces recall of jaw, face or cranial implants due to risk of infection

If you’ve had a Stryker Custom Cranial Implant surgically implanted to correct lower, upper jaw, face or cranium defects due to injury you’ll need to read the FDA Announcement and contact the surgeon who performed the surgery. You are at risk of infection.

All hospital administrators need to check supply shelves and return the kits.

If any patient needs assistance contact our office. The FDA Alert is below with the necessary link.

 

Stryker Custom Cranial Implant Kits

 

Audience: Maxillofacial surgeons, hospital risk managers

Stryker Leibinger USA and FDA notified healthcare professionals of a Class 1 recall of all sizes of the cranial implant kit distributed from November 5, 2007 through October 23, 2008. The company is recalling these products because sterility cannot be assured. Custom cranial implants are designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face. Implanting surgeons were notified individually of the problem in a October 24, 2008 recall letter. The letter advised them of the risk for serious infections, and instructed them to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits.

 

Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Stryker

FDA announces recall of jaw, face or cranial implants due to risk of infection

If you’ve had a Stryker Custom Cranial Implant surgically implanted to correct lower, upper jaw, face or cranium defects due to injury you’ll need to read the FDA Announcement and contact the surgeon who performed the surgery. You are at risk of infection.

All hospital administrators need to check supply shelves and return the kits.

If any patient needs assistance contact our office. The FDA Alert is below with the necessary link.

Stryker Custom Cranial Implant Kits

Audience: Maxillofacial surgeons, hospital risk managers
Stryker Leibinger USA and FDA notified healthcare professionals of a Class 1 recall of all sizes of the cranial implant kit distributed from November 5, 2007 through October 23, 2008. The company is recalling these products because sterility cannot be assured. Custom cranial implants are designed individually for each patient to correct trauma and/or defects in the lower jaw, upper jaw and face or the cranium and the face. Implanting surgeons were notified individually of the problem in a October 24, 2008 recall letter. The letter advised them of the risk for serious infections, and instructed them to follow-up with patients for infections for at least six months after surgery. The recall letter also included details for identifying and returning any remaining implant kits.

Read the complete MedWatch 2008 Safety summary, including a link to the Class 1 recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Stryker

UPC – Bar Code is improperly coded which may lead to overdosing patients

We’ve been talking about bar codes, UPC’s, and today the FDA put out an alert concerning an incorrect bar code that could cause patients to be overdosed. The question remains about how we can protect ourselves from food poisoning and melamine when we can’t easily determine the country of origin at the point of sale?

Here is the FDA Alert:

Hospira, Inc. notified healthcare professionals of a recall of one lot (lot number 65-620-FW, expiration date May 1, 2010, NDC 0409-7902-09) of 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP in 1000 mL flexible plastic containers. A small number of the containers may be incorrectly labeled with a bar code for 5% Dextrose Injection, USP (NDC 0409-7922-09). The incorrect bar code could lead to a medication error resulting in the wrong drug being delivered to a patient if a bar code system is used to confirm the medication. Potential adverse events related to an error of this type include electrolyte imbalance, cardiac dysfunction, gastrointestinal disturbances, paresthesia and mental confusion. The affected lot was shipped to U.S. customers between July 2008 and September 2008. Healthcare facilities with an existing inventory should quarantine the product immediately and call Hospira Customer Care at 1-877-946-7747 for instructions on how to return it.

Read the MedWatch 2008 safety summary, including a link to the company's press release, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#20meqPotChlor 

Unsafe Products - Transvaginal Placement of Surgical Mesh

Transvaginal Placement of Surgical Mesh

Audience: Hospital surgical staff, OB/GYN physicians, other healthcare professionals
FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks. 

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding the above issue at:  http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mesh