MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE ABSOLUTE WATERPROOF TAPE; 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	Pain (1994); Burning Sensation (2146); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age, weight, ethnicity : information not provided.The product has a 5 year shelf life claim.No sample has been returned to 3m for evaluation.Root cause of reported issue could not be established.
Event or Problem Description
A male customer (age unspecified) reported an incident regarding the nexcare¿ absolute waterproof tape.He alleged the tape caused 2nd degree burns and left raised blisters on his skin.He applied the tape at about 10 pm on wednesday (b)(6) 2021 on his right underarm.He was covering a surgical incision.He applied antibiotic cream on the wound, gauze and then taped the edges with the tape.He alleged he felt burning and itching under the tape.The tape was removed the morning of (b)(6) 2021.The tape was not difficulty to remove.He alleged the area was red, painful and bled when he removed the tape.He alleged he washed the area with water and the redness turned into blisters.The alleged injury was only in the area where the tape was applied on his skin.He followed up with his doctor on thursday (b)(6) 2021 and the doctor prescribed an antibiotic (type was not specified) for the surgical wound (not for the alleged blisters).On (b)(6) 2021, he went to the dermatologist, who alleged the injury is a chemical burn and prescribed 1% silver sulfadiazine cream to apply on the area.He alleged it hurts every time he moves his arm or gets his arm wet.He is worried the area may get infected.No allergies or medical history reported.

• 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
• MDR Report Key: 11808987
• Report Number: 2110898-2021-00031
• Device Sequence Number: 19716541
• 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): 05/11/2021

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: 732
• Device Lot Number: 20356J
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/11/2021
• 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