MAUDE Adverse Event Report: ASO LLC Walgreens; WATERPRROF SMART-FLEX ADHESIVE BANDAGES

Model Number	UPC#311917011332
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On the initial report received on 08/11/2026, the consumer stated that he took a shower, and when he removed the bandage, it took the skin off with it.
Additional Manufacturer Narrative
As of 09/02/2026 aso was unable to retrieve the lot number information or unused return product.Aso reviewed records of biocompatibility tests, latex screening and ript test with no issues reported.Refer to section b.6 of this report for further details.Udi notes: the expiry date is not present on device label.

• Brand Name: Walgreens
• Common Device Name: WATERPRROF SMART-FLEX ADHESIVE BANDAGES
• Manufacturer (Section D): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer (Section G): ASO LLC; 300 sarasota center blvd.; sarasota FL 34240
• Manufacturer Contact: 300 sarasota center blvd.; +1(941)379-0300
• MDR Report Key: 50689816
• Report Number: 1038758-2026-00023
• Device Sequence Number: 9684454
• Product Code: KGX
• UDI-Device Identifier: 00311917011332
• UDI-Public: 00311917011332
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: UPC#311917011332
• Device Catalogue Number: 831245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male