UP&UP
Received Jun 4, 2026 · Event occurred May 18, 2026
Report 1038758-2026-00014 · MDR key 25394868
Device
Generic name
Large Adhesive Pads
Manufacturer
Aso LlcModel number
UPC#017276226355Catalog number
ITEM #245-07-0726
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Burning Sensation
- Skin Inflammation/ Irritation
Narrative
Description of Event or Problem
IN THE INITIAL REPORT RECEIVED ON (B)(6) 2026, THE CONSUMER STATED THAT THE PRODUCT LEFT A RED MARK AND CAUSED A BURN. ACCORDING TO THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON (B)(6) 2026, THE CONSUMER CLARIFIED THAT SHE USED THE PRODUCT POST-SURGERY. SHE REPORTED THAT THE ADHESIVE BURNED HER SKIN. CONSUMER RETURNED THE PRODUCT TO THE STORE. THE CONSUMER RETURNED THE PRODUCT TO THE STORE AND HAD THE AFFECTED AREA EXAMINED BY HER DOCTOR, WHO CONFIRMED THE REACTION APPEARED TO BE CAUSED BY THE ADHESIVE. THE CONSUMER STATED THAT THE ISSUE WAS WITH THE TAPE AREA AND THAT SYMPTOMS RESOLVED AFTER SHE DISCONTINUED USING THE PRODUCT. HOWEVER, SHE STATED THAT SHE STILL HAS SCARRING.
Additional Manufacturer Narrative
AS OF (B)(6) 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.