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

Catalog Number	771-1PK
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Irritation (2076)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: online review date used as the d.O.E.Product lot # not provided, therefore manufacture date is unknown.No sample or photos were provided to 3m for evaluation.Root cause of reported issue was not established.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.End of report.
Event or Problem Description
A consumer reported via an online review that they applied the referenced tape.Date, duration and location of wear were not specified.The tape was reportedly used to secure gauze.The consumer alleged they developed contact dermatitis due to tape use.No known allergies/skin sensitivities were specified.The consumer reported they used prednisone to treat the reaction.No further information was provided.

• 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
• MDR Report Key: 9686583
• Report Number: 2110898-2020-00009
• Device Sequence Number: 3654833
• Product Code: KGX
• UDI-Device Identifier: 00051131652996
• UDI-Public: 051131652996
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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: No Information
• Device Catalogue Number: 771-1PK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/10/2020
• 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