NEOSPORIN SCAR SHEETS
Received Aug 29, 2006 · Event occurred Aug 9, 2006
Report 2246407-2006-00005 · MDR key 756875
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Pfizer, Inc.Model number
UNKCatalog number
UNK
Lot number
22040-27
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
71 YR
- Other (for use when an appropriate patient code cannot be identified)
- Therapy/non-surgical treatment, aborted/stopped
- Treatment with medication(s)
Narrative
Description of Event or Problem
A FEMALE CONSUMER APPLIED PART OF A NEOSPORIN SCAR SHEET (SILICONE) ONCE DAILY BEGINNING IN 2006, TO A SCAR ON HER FACE FROM RECENT MOLE REMOVAL SURGERY. TWO DAYS LATER, SHE HAD HIVES. SHE CONTINUED PRODUCT USE AND THIRTEEN DAYS LATER, THE HIVES WERE ALL OVER HER BODY. THE CONSUMER WENT TO THE ER THAT SAME DAY, WHERE SHE WAS TREATED WITH THREE UNSPECIFIED INJECTIONS AND BENADRYL (UNSPECIFIED). PRIOR TO THAT DAY, PRODUCT USE WAS DISCONTINUED AND THE EVENT RESOLVED.
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED FOR FAILURE ANALYSIS/LABORATORY TESTING. IT CANNOT BE RULED OUT THAT THE PRODUCT MAY HAVE POSSIBLY CAUSED THE EVENT.