BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCARAWAY SILICONE SCAR GEL

    MDR report key: 17878029 · Received October 5, 2023

    Report

    Report Number
    3019867040-2023-00003
    Event Type
    Injury
    Date Received
    October 5, 2023
    Report Date
    September 27, 2023
    Manufacturer
    ALLIANCE PHARMA INC.
    Product Code
    MDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT QUALITY INVESTIGATION IS ONGOING AND WE HAVE BEEN UNABLE TO DETERMINE TRUE CAUSE OF CONSUMER'S CONTACT DERMATITIS. WHILE THE PRODUCT USED BY CONSUMER WAS NOT AVAILABLE FOR EVALUATION, A LOT # AND EXPIRATION DATE WAS PROVIDED. BATCH REVIEW WAS CONDUCTED AND SHOWED NO ABNORMALITIES OR INCONSISTENCIES. THIS EVENT IS CONFOUNDED BY REPEATED ATTEMPTS TO REMOVE THE SCARAWAY GEL BY USE OF "DAWN PLATINUM" (DISH SOAP) WITH A HOT COTTON BALL WHICH LIKELY INITIATED AND AGGRAVATED THE SYMPTOMS OF BLEEDING, RAW FACE AND PAIN DIAGNOSED AS "CONTACT DERMATITIS" REFERRED LATER BY CONSUMER AS "CHEMICAL BURN". IT IS POSSIBLE THAT THE CONSUMER MISTAKEN THE EXUDATE FORMING THE CLEAR SHINY LAYER, FROM NATURAL HEALING OCCURRING AFTER THE REPEATED SKIN INJURY FROM HER REPEATED ATTEMPTS TO REMOVE WHAT SHE CONSIDERED TO BE GEL. NO IMMEDIATE SKIN IRRITATION, BURNING, RASH, ITCHING OR ALLERGIC REACTION COMPLAINTS WERE REPORTED WITH THE USE OF SCARAWAY GEL, UNTIL AFTER THE REPEATED ATTEMPT TO REMOVE THE GEL.

    Description of Event or Problem · 0

    ON (B)(6) 2023 CONSUMER REPORTED EXPERIENCING "CHEMICAL BURN" AFTER CONTINUED ATTEMPTS TO REMOVE (SPILLED) SCARAWAY GEL FROM HER FACE. THE CONSUMER HAD PLASTIC SURGERY ON (B)(6) 2023, WITH SURGICAL SCARS WERE LOCATED ON THE FACE IN FRONT OF EACH EAR. ON (B)(6) 2023, SHE HAD THE STITCHES REMOVED WITH THE WOUND(S)/INCISIONS FULLY HEALED. SURGEON RECOMMENDED THE USE OF SCARAWAY GEL. SHE HAS NO PRE-EXISTING SKIN CONDITIONS AND TAKES LEVOTHYDROXINE (50 MG) FOR HYPOTHYROID. SHE USED SCARAWAY GEL ONLY ONCE ON (B)(6) 2023 AND REPORTED THE INCIDENT OF SCARAWAY GEL APPLICATOR BALL POPPED OUT CAUSING THE GEL TO SPREAD ONTO AND NEAR THE SCAR AREA LOCATED ON THE FACE IN FRONT OF EACH EAR. SHE THEN USED HER FINGER AND "APPLIED IT LIKE DEODORANT," BUT APPLIED IT TOO THICKLY AND WAS UNABLE TO WIPE THE PRODUCT OFF. SHE REPORTED COMPLAINT OF "SCARAWAY GEL REMAINED ON MY SKIN" AND EXPERIENCED "HARD TO MOVE MY HEAD LEFT TO RIGHT OR UP AND DOWN" ON AN UNKNOWN DATE. ON (B)(6) 2023, SHE CONTACTED CUSTOMER SERVICE AND WAS ADVISED THAT THE GEL CAN BE REMOVED WITH WATER AND A SOAP/DETERGENT, LIKE DAWN. ON (B)(6) 2023, AFTER UNKNOWN NUMBER OF REPEATED USE OF "DAWN PLATINUM" (DISH SOAP) WITH A HOT COTTON BALL SHE COMPLAINT OF EXPERIENCING SKIN BLEEDING, RAW FACE AND PAIN AROUND THE OPERATION SIGHT ON FACE. SHE ALSO COMPLAINT OF THICK LAYER OF THE SILICON GEL WHICH LOOKED CLEAR AND SHINY. SHE WAS ADVISED MULTIPLE TIMES TO DISCONTINUE ATTEMPTING TO REMOVE AND TO GO SEE HER DOCTOR. SHE REPORTED USE OF "DAWN PLATINUM" (DISH SOAP) UNTIL SHE COULD "NO LONGER TAKE THE PAIN AND WENT TO THE ER." SHE DID NOT SEEK ANY ADDITIONAL MEDICAL ADVICE PRIOR TO HER VISIT TO ER ON (B)(6) 2023, WHERE SHE WAS DIAGNOSED WITH "CONTACT DERMATITIS" AND PRESCRIBED CEFADROXIL AND METHYLPREDNISOLONE. SHE WAS REFERRED TO "EITHER WOUND CENTER OR BURN CENTER OR DERMATOLOGIST" FOR FOLLOW UP. LATER, ON AN UNKNOWN DATE SHE VISITED HER SURGEON AND WAS PRESCRIBED DOXYCYCLINE 50 MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087521 SCARAWAY SILICONE SCAR GEL SCARAWAY GEL MDA ALLIANCE PHARMA INC. 537

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other LEVOTHYDROXINE 50MG.