MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE¿ ABSOLUTE WATERPROOF TAPE; TAPE AND BANDAGE, ADHESIVE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rash (2033); Blister (4537)
Date of Event	10/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A male customer (age unspecified) reported an incident regarding the nexcare absolute waterproof tape.He used the tape to secure a foot sock.On (b)(6) 2022, he alleged the tape caused blisters and severe skin rash on the area.No additional information provided.No allergies, medical history intervention reported.
Additional Manufacturer Narrative
No sample has been returned to 3m for evaluation.Root cause of reported issue could not be established.End of report.

• Brand Name: NEXCARE¿ ABSOLUTE WATERPROOF TAPE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 15911595
• Report Number: 2110898-2022-00124
• Device Sequence Number: 5362031
• Product Code: KGX
• UDI-Device Identifier: 00051135811153
• UDI-Public: 051135811153
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

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
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 731
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Male