ScarAway Silicone Clear Scar Sheets Lot CodeRecalls & reported problems
Alliance Pharma Inc. · ScarAway Silicone Clear Scar Sheets, 6ct AP · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00358962203305), received between Aug 15, 2025 and Aug 15, 2025 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Deformity/ Disfigurement1
- Erythema1
- Hypersensitivity/Allergic reaction1
- Inflammation1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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. O
Patient problems: Deformity/ Disfigurement; Erythema; Hypersensitivity/Allergic reaction; Inflammation; Pain
MAUDE report 22817112 ↗
Other Elastomer, Silicone, For Scar Management devices
- EPI-DERM EDGTNT-5106Biodermis LLC · Elastomer, Silicone, For Scar Management1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page