SCARAWAY CLEAR SILICON SCAR SHEETS

Description of Event or Problem

CONSUMER CALLED CUSTOMER SERVICE ON (B)(6) 2023 AND STATED SHE APPLIED SCARAWAY CLEAR SILICONE SCAR SHEETS TO HER BREAST IN THE THIRD OR FOURTH WEEK OF HEALING FOLLOWING BREAST RECONSTRUCTIVE SURGERY (SECONDARY TO BREAST CANCER) PER DIRECTION FROM HER MEDICAL PROVIDER. CONSUMER REPORTS THE WOUNDS WERE FULLY CLOSED WITHOUT ANY OOZING, CRUSTING, SCABBING, OR ANY OTHER INDICATION OF OPEN WOUND. CONSUMER STATES SHE HAD A REACTION THAT COMPRISED OF "PUS FILLED SACS AS WELL AS HIVES" THAT SPREAD OUTSIDE OF SCAR MARGINS/APPLICATION SITE ALL THE WAY UP HER BREAST ON THE 4TH DAY OF WEAR. SHE HAD INITIALLY ASSUMED THE REDNESS/SKIN IRRITATION WAS DUE TO SUNBURN/SUN EXPOSURE, BUT NOTICED LATER IN THE DAY THAT SHE HAD SYMPTOMS ON HER BREAST IN AREAS THAT WERE NOT EXPOSED TO THE SUN. CONSUMER STATE SHE DID SEEK MEDICAL ATTENTION AND RECEIVED A PREDNISONE SHOT, BENADRYL, AND CORTISONE CREAM. UPON FURTHER FOLLOW UP WITH THE CONSUMER AFTER INITIAL CONTACT, CONSUMER CONFIRMED THAT THE WOUND WAS HEALED WHEN SHE APPLIED THE SHEETS, AND CLAIMS THAT THE USE OF THESE SCAR SHEETS CAUSED ADDITIONAL SCARRING TO HER BREASTS. PER CONSUMER, HER PHYSICIAN HYPOTHESIZED THAT THIS WAS THE RESULT OF AN ALLERGIC REACTION TO THE SILICONE IN SCARAWAY CLEAR SILICONE SCAR SHEETS. PER ALLIANCE PHARMA INC. SAFETY PHYSICIAN, BASED ON THE AVAILABLE INFORMATION CONSIDERING THE TEMPORAL RELATIONSHIP, LACK OF ALTERNATE CAUSES, AND A POSITIVE DECHALLENGE OF SCARAWAY CLEAR SHEETS CANNOT BE EXCLUDED, HENCE THE CAUSALITY IS CONSIDERED POSSIBLE FOR THE REPORTED EVENTS.

Additional Manufacturer Narrative

DUE TO THIS BEING MANUFACTURER'S FIRST ELECTRONIC REPORT, THE SUBMISSION WAS DELAYED DUE TO DIFFUCULTIES WITH IT SET UP. ALLIANCE PHARMA ATTEMPTED TO REPORT THIS EVENT VIA MAIL AND IT WAS REJECTED. ALLIANCE PHARMA HAS COMMUNICATED WITH THE FDA ABOUT THIS ISSUE (JULY 20TH, 2023) AND WAS ADVISED TO MAKE A NOTE ON THE DELAY IN SECTION H OF THIS FORM.