MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE¿ CUSHIONED 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	Erythema (1840); Skin Irritation (2076)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information was not provided.Product lot # was not provided.This product has a 5-year shelf life.Initial reporter's occupation was not specified.Product lot # was not provided, therefore device manufacture date is unknown.No sample has been returned by the customer for evaluation and no lot number has been reported.A photo of the alleged injury was provided.The complaint history, related to the reported product, was reviewed for the last 24-month period.No statistical trend was observed.Based on information provided, 3m was unable to determine root cause.3m will continue to monitor.
Event or Problem Description
A female consumer (age not specified) applied one bandage, during the morning, to cover an unspecified stitched wound on approximately (b)(6) 2020.The consumer alleged she noticed a skin reaction when the bandage was changed in the late afternoon that same day.Exact duration of bandage wear was not specified.The consumer immediately stopped using the bandages after the alleged reaction was discovered.The reaction was described as reddened skin, in the shape of a rectangle, around the initial wound area.The affected area reportedly became redder after showering.The consumer reported that she has sensitive skin, flower allergy and other unspecified allergies.The consumer visited a doctor on (b)(6) 2020 to remove the existing stitches.The doctor viewed the affected skin area and prescribed an rx cortisone cream.The doctor reportedly advised the consumer that it may take some time for the skin area to go back to normal color.

• Brand Name: NEXCARE¿ CUSHIONED WATERPROOF BANDAGES
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul, mn
• MDR Report Key: 10143635
• Report Number: 2110898-2020-00029
• Device Sequence Number: 19796383
• Product Code: KGX
• UDI-Device Identifier: 00051131997172
• UDI-Public: 051131997172
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 06/11/2020

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 522-08CB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/11/2020
• 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: Other; Required Intervention