SCARAWAY SILICONE SHEET

Description of Event or Problem

THE CONSUMER BEGAN USING SCARAWAY SILICONE SHEETS IN APPROXIMATELY (B)(6) 2019 TOPICALLY TO BOTH BREASTS FOR SCAR TREATMENT DUE TO BREAST AUGMENTATION BY RECOMMENDATION OF HER HCP. THE CONSUMER USED 2 SHEETS FROM THIS MOST RECENT UNKNOWN LOT AND HAD NOT HAD ANY PRIOR ISSUES WITH USE. SHE NOTED THAT ON (B)(6) 2020 THE PRODUCT CAUSED A SEVERE BURN TO THE RIGHT BREAST. SHE DISCONTINUED USE ON (B)(6) 2020, NEVER TO BE REINTRODUCED. CONSUMER HAD TO HAVE SURGERY TO CLOSE THE BURN UP ON (B)(6) 2020 AND WAS GIVEN STEROIDS, ANTIBIOTICS AND CREAM TO APPLY TID WITH BANDAGES FOR TREATMENT; WHICH HEALED THE BURN ON APPROXIMATELY (B)(6) 2020. SINCE (B)(6) 2020 HER BURN SCAR ON THE RIGHT BREAST IS ONGOING. CONSUMER ADVISED SHE HAS A FOLLOW UP APPOINTMENT SCHEDULED IN 3 WEEKS AND WAS ADVISED BY THE HCP SHE MAY HAVE TO HAVE CORRECTIVE SURGERY NOW AND LASER TREATMENT TO REMOVE THE SCAR.