NEOSPORIN SCAR SOLUTION
Received May 23, 2007 · Event occurred May 16, 2007
Report 2246407-2007-00002 · MDR key 855338
Device
Product problems
- Unknown (for use when the device problem is not known)
Patient
61 YR
- Erythema
- Necrosis
- Surgical procedure
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
A FEMALE CONSUMER USED 1/2 A PATCH OF NEOSPORIN SCAR SOLUTION (SILICONE) 16 HOURS DAILY IN 2007 TO REDUCE A SCAR ON HER SHOULDER DUE TO SURGERY TWO WEEKS PRIOR TO USE OF THE PROD. APPROX ONE MONTH LATER, SHE BEGAN TO NOTICE A REDNESS AROUND THE APPLICATION SITE AREA. ABOUT 3-4 DAYS LATER (EXACT DATE UNSPECIFIED) SHE CONSULTED WITH HER SURGEON WHO STATED THAT SHE HAD NECROTIC TISSUE UNDER HER SKIN. SEVERAL UNSPECIFIED TESTS WERE PERFORMED AND IT WAS NOTED THAT THERE WAS NO BACTERIAL OR VIRAL INFECTION. SHE ALSO REPORTED THAT THE AFFECTED AREA BEGAN GROWING IN SIZE AND WAS CURRENTLY ABOUT 2 INCHES BY 4 INCHES. SHE HAS BEEN RETURNING TO HER PHYSICIAN EVERY TWO DAYS TO HAVE THE "LIQUIFIED TISSUE" (FLUID) REMOVED THROUGH A SYRINGE. AT ABOUT 2 WEEKS LATER, CONSUMER STATED THAT SHE WAS SCHEDULED TO GO TO SURGERY THAT MORNING AND WAS UNAVAILABLE FOR FOLLOW-UP. PROD USE WAS DISCONTINUED ONE DAY PRIOR TO NOTICE A REDNESS AROUND THE SITE AREA. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS RESOLVED.
Additional Manufacturer Narrative
ANALYSIS/LAB TESTING. IT CANNOT BE RULED OUT THAT THE PROD MAY HAVE POSSIBLY CAUSED THE EVENT.