MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE FLEXIBLE CLEAR TAPE; TAPE AND BANDAGE, ADHESIVE

Catalog Number	779
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: information was not provided.Device lot number was not provided.Lot number was not provided.Therefore, manufacture date unknown.No sample has been received for analysis.The 2-year complaint history was reviewed for the product's global sales code (gsc) of szp and reported failure.No trends were observed.3m will continue to monitor.Test results confirm the biocompatibility of nexcare¿ flexible clear tape 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 (age unspecified) reported an incident regarding the nexcare¿ flexible clear first aid tape.On an unspecified date, the bandage was applied over another brand of bandage covering a draining sore (type of drainage was not reported) on her ankle (exact location was reported).A couple of days later, she allegedly broke out in a rash on her stomach, chin, arms and the back of her ears.She alleged her lower arm was also slightly swollen.On an unspecified date, the doctor prescribed triamcinolone acetonide ointment usp 0.1% for the rash.No allergies, medical history or intervention reported.

• Brand Name: NEXCARE FLEXIBLE CLEAR TAPE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 12577078
• Report Number: 2110898-2021-00061
• Device Sequence Number: 11606989
• Product Code: KGX
• UDI-Device Identifier: 00051131669949
• UDI-Public: 00051131669949
• 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): 10/05/2021

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 Catalogue Number: 779
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 10/05/2021
• 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: Required Intervention