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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Rash (2033); Blister (4537)

Event Date 10/20/2022

Event Type  Injury  

Event Description

Applied nexcare absolute waterproof tape to secure foot socks.The tape caused blisters and severe skin rash where the tape was wrapped.

• Brand Name: NEXCARE ABSOLUTE WATERPROOF TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 15667804
• MDR Text Key: 302440942
• Report Number: MW5112821
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/21/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 DA
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White