ALL-HEALTH
Received Jun 4, 2026 · Event occurred May 12, 2026
Report 1038758-2026-00013 · MDR key 25394295
Device
Generic name
Waterproof Extra Large Strong Strips Adhesive Bandages One Size
Manufacturer
Aso LlcProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Rash
Narrative
Description of Event or Problem
ACCORDING TO THE INITIAL REPORT RECEIVED ON MAY 12, 2026, THE CONSUMER STATED THAT SHE HAD A GROWTH REMOVED BY A DERMATOLOGIST. THE PRODUCT WAS APPLIED TO COVER THE AREA AND CAUSED ITCHING AND A RASH WITHIN 24 HOURS OF USE. THE CONSUMER RETURNED TO THE DERMATOLOGIST, WHO DETERMINED THAT THE BANDAGE CAUSED THE RASH AND ADVISED LEAVING THE WOUND UNCOVERED UNTIL THE STITCHES ARE REMOVED
Additional Manufacturer Narrative
AS OF 06/04/2026, ASO WAS UNABLE TO RETRIEVE THE LOT NUMBER INFORMATION OR UNUSED RETURN PRODUCT. ASO REVIEWED RECORDS OF BIOCOMPATIBILITY TESTS, LATEX SCREENING TEST WITH NO ISSUES REPORTED. REFER TO SECTION B.6 OF THIS REPORT FOR FURTHER DETAILS.