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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Rash (2033); Blister (4537)

Event Date 10/20/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304777336
• Report Number: 2110898-2022-00124
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 00051135811153
• UDI-Public: 051135811153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 731
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male