BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCARAWAY SILICONE CLEAR SCAR SHEETS

    MDR report key: 22817112 · Received August 15, 2025

    Report

    Report Number
    3019867040-2025-00001
    Event Type
    Injury
    Date Received
    August 15, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 14, 2025
    Manufacturer
    BIO MED SCIENCES, INC.
    Product Code
    MDA
    UDI-DI
    00358962203305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS DELAYED DUE TO ISSUES SUBMITTING USING USP NEXTGEN. INITIAL REPORTING OF SYMPTOMS ON 15-MAY-2025 WAS INITIALLY LABELED AS A NON-SERIOUS, NON-REPORTABLE ADVERSE EVENT. ON (B)(6) 2025, CONSUMER ADVISED "DERMATOLOGIST THINKS THEY ARE PERMANENT" IN RELATION TO THE INDENTATIONS ON HER FACE. AT THAT TIME, WE DETERMINED THE CASE TO BE A SERIOUS ADVERSE EVENT AND REPORTABLE TO THE FDA. MANUFACTURER HAS USED SAME HEALTH EFFECT CLINICAL CODES AS CONSUMER IN REPORT MW5172877.

    Description of Event or Problem · 0

    CUSTOMER CALLED OUR CUSTOMER SERVICE ON (B)(6) 2025, STATING SHE WORE A SHEET ON HER FACE FOR AT LEAST 1-2 DAYS, AND WHEN SHE REMOVED THE SHEET IT "LEFT AN INDENTATION OF A RECTANGLE WHERE THE SHEET WAS PLACED" AND WAS SEEKING ADVICE. CUSTOMER SERVICE ADVISED CUSTOMER TO DISCONTINUE USE AND SPEAK TO A PHYSICIAN. ON (B)(6) 2025, CUSTOMER WROTE IN VIA WEBSITE CONTACT FORM, STATING: "I USED A SCARAWAY SHEET ON MY PALM AND ON A SCAR ABOVE MY NOSE ON MY FACE. THE PALM SCAR BECAME INFLAMED AND HURT FOR MANY DAYS. THE AREA ABOVE MY NOSE BETWEEN MY EYEBROWS HAS DEEP INDENTATIONS. I HAVE GONE TO MY DOCTOR AND WAS REFERRED TO A DERMATOLOGIST. I ONLY WORSE THE SHEET OVERNIGHT FOR 7 HOURS ON MY FACE- IT STATES CAN BE FOR ANY PART OF THE BODY. I AM UPSET THAT THERE WAS NO WARNING ON THE INERT THAT THIS COULD CAUSE ME SO MUCH HARM AND PAIN, NO WARNING ABOUT TESTING FIRST, AND NO WARNING HOW IT MIGHT AFFECT OLDER SKIN. I MAY NEED TO SEE A PLASTIC SURGEON NEXT." ON (B)(6) 2025, CUSTOMER PROVIDED US WITH RECEIPT/BARCODE FOR A REFUND. IT WAS DETERMINED CONSUMER BOUGHT PRODUCT FROM UNAUTHORIZED RESELLER "WSNBB" ON WALMART.COM, NOT ALLIANCE PHARMA INC. AS PER ALLIANCE POLICY, NO REFUND WAS PROVIDED. ON (B)(6) 2025, CONSUMER WROTE IN VIA WEBSITE CONTACT FORM, STATING "THIS PRODUCT CAUSED ME GREAT HARM. THE EDGES OF THE SHEET LEFT DEEP DEPRESSIONS ON MY FACE. ON MY PALM, I HAD A RAISED WELT ON MY CARPAL TUNNEL SITE THAT WAS RED AND I COULD NOT TOUCH IT FOR MANY WEEKS AS IT WAS VERY PAINFUL. THE INSERT DOES NOT SAY TO TEST FIRST. THE INSERT SAYS, 'CAN BE USED ON ANY PART OF THE BODY.' I FOLLOWED DIRECTIONS. I DID NOT MISUSE IT. THIS PRODUCT PUT DEEP WRINKLES ON MY PACE. DERMATOLOGIST THINKS THEY ARE PERMANENT. YOU MUST CHANGE INSERT.YOU MUST WARN OTHERS OF A POSSIBLE ALLERGIC REACTION." ON (B)(6) 2025, CONSUMER WROTE IN VIA EMAIL, STATING "SCARAWAY MESSED UP MY FACE (I HAVE DEEP GROVES BETWEEN MY EYES WHERE EDGES OF THE STRIP WERE AND OTHER DEEP LINES WHERE THE SKIN WAS PUSHED AND PITTED. A DERMATOLOGIST SAYS THESE ARE TOO DEEP AND WILL NOT GO AWAY. I HAVE USED PRESCRIPTION RETINOL CREAM AND NO RESULTS!) I ALSO HAD AN INFLAMMATION ON MY PALM OF MY HAND FOR WEEKS. DOCTORS COULD NOT TOUCH THE RED ANGRY MOUND THAT DEVELOPED THERE." CUSTOMER SERVICE REACHED OUT TO THE CONSUMER TO ATTEMPT TO GATHER LOT # INFO ON 25-JUL-2025. CONSUMER REITERATED SHE IS NOT HAPPY WITH THE EXPERIENCE SHE HAD. SHE STATED SHE DID NOT HAVE ANY WRINKLES ON HER FOREHEAD OR BETWEEN HER EYEBROWS PRIOR TO USING SCARAWAY. SHE REPORTS SHE WAS GOING TO "HAND THERAPY" AND WAS "ALMOST HEALED." CONSUMER EMAILED PHOTOS OF PACKAGING PER CUSTOMER SERVICE REQUEST ON (B)(6) 2025. SHE ALSO STATED "I SUFFERED GREAT PAIN ON MY PALM FOR 2 WEEKS AND HAVE DEEP GROOVES ON MY FACE. I HAVE HAD 2 FAMILY DOCTOR VISITS, 1 DERMATOLOGY VISIT, AND I SEE A PLASTIC SURGEON FOR CONSULTATION ON TUESDAY, (B)(6) 2029. THIS PRODUCT HAS CAUSED ME GREAT HARM." PER CUSTOMER'S MDR REPORT # MW5172877, SHE REPORTS SHE WAS INITIALLY REFERRED TO USE SCARAWAY AFTER SHE SAW A PHYSICAL THERAPIST "FOR A SCAR THAT WAS NOT HEALING PROPERLY AFTER CARPAL TUNNEL SURGERY" WHERE SHE WAS GIVEN A SAMPLE AND ADVISED TO PURCHASE SCARAWAY. SHE NOTES "MY HAND WAS HEALING, AND THE SCAR WAS NO LONGER AS HARD AND HAD BECOME FLATTER" WITH THE SAMPLE. WHEN SCARAWAY ARRIVED, SHE "(BEFORE THE REACTION ON THE PALM SET IN)...DECIDED TO TRY IT ON A SCAR NEAR MY EYEBROW... THE EDGES OF THE STRIP LEFT DEEP GROOVES IN MY FOREHEAD BETWEEN MY EYES, PUSHED MY SKIN SO I DEVELOPED A RECTANGULAR SHAPE WRINKLE BOX OVER MY RIGHT EYEBROW, AND PRODUCED LINES ON THE BRIDGE OF MY NOSE AND FOREHEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2787844 SCARAWAY SILICONE CLEAR SCAR SHEETS SCARAWAY CLEAR SHEETS MDA BIO MED SCIENCES, INC. 00358962203305

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention ALLEGRA| CALCIUM| FLONASE| GLUCOSAMINE CHONDROTIN| LEVOTHYROXINE| MONTELUKAST| PROBIOTIC| RECLAST| SIMVASTATIN| SUDAFED| VOLAREN| ZINC