Investigation Into Burned Cornea Draws Warning Letter

The FDA has warned devicemaker Duro-Med Industries for several GMP violations related to its hot and cold compresses, including failure to investigate a complaint about a burned cornea.

While a physician’s assistant was breaking the Compress Instant Ice Junior to mix the inner ingredients, the mixture squirted out of a “previously unknown slit” and into the assistant’s eye, according to the complaint. The assistant was diagnosed with a burned cornea.

Duro-Med’s complaint summary indicated there was no response from the complainant about sample information or availability as of last December, an FDA warning letter says. It adds there was no follow-up with the customer, and the complaint status remains open, awaiting customer callback.

According to the letter, the company failed to submit medical device reports within 30 days of learning of that event and the two other complaints, one in which the Compress Instant Ice Junior leaked into a patient’s eye. The complaint summary indicated the lot number provided by the complainant was invalid and therefore a thorough investigation could not be performed.

The other complaint was reported after a patient using the Compress Instant Ice Junior for roughly 15 minutes received frostbite on the lower back. The complaint summary indicated the end user did not follow the instructions for use.

The company did not return telephone calls seeking comment.

SOURCE: FDANEWS