MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE(TM) WATERPROOF BANDAGES; TAPE AND BANDAGE, ADHESIVE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Local Reaction (2035); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has a 5 year shelf life claim.No sample has been received for analysis.The 2-year complaint history was reviewed for the product's global sales code (gsc) of sxj and reported failure.No trends were observed.3m will continue to monitor.Test results confirm the biocompatibility of nexcare¿ waterproof bandages for their intended use.In addition to performing clinical studies, 3m¿ monitors its medical devices with manufacturing controls, including in-process specifications, release specifications and testing.
Event or Problem Description
A female customer alleged that her 10 years old daughter had a severe allergic reaction to the nexcare waterproof bandages.Her daughter had a wart infection.She applied an over the counter wart medicine (medication unspecified) to the area before she applied the nexcare bandage.One bandage was applied to her right knee and another bandage was applied to her right inner thigh.She used the bandage for 3 consecutive days.The bandage was in place for about 16-24 hours and was changed daily.She first noticed the alleged injury on (b)(6) 2021.She alleged the area was red, bubbly and looked like a blister.She treated the areas with a steroid cream (triamcinolone acetonite ointment) that was prescribed by the doctor.The alleged injury is resolving.She reported that her daughter is allergic to hay fever and had a past allergic reaction to latex tape after routine infant immunization.No medical history reported.

• Brand Name: NEXCARE(TM) WATERPROOF BANDAGES
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 11546393
• Report Number: 2110898-2021-00019
• Device Sequence Number: 3764495
• Product Code: KGX
• UDI-Device Identifier: 00051131212763
• UDI-Public: 051131212763
• 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): 03/22/2021

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: 432-100
• Device Lot Number: 20232M
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 10 YR