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 Code	Injury (2348)
Date of Event	09/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No information was provided.Product shelf life is 5 years from the date of manufacture.Initial reporter's occupation was not provided.The product has not been received for evaluation.The complaint history was reviewed for the past 24 months for product global sales code (sxj), lot 19136m and defined failure code.No trends were observed.3m will continue to monitor.
Event or Problem Description
A female consumer applied one large sized referenced bandage to cover a round-shaped sore on her right elbow.The wound area was reportedly covered with band-aid® brand bandages for a few days prior to use.Prior to application, the skin area was rinsed with water and neosporin® was applied on the wound.The bandage was removed 24 hours after application.The consumer reported the bandage was extremely difficult to remove.She alleged a layer of skin was taken off during removal.Removal technique was not specified.The affected area was reportedly bright red, sore, raw, slightly bled and painful.No known allergies/skin sensitivities were specified.The customer visited a doctor and was prescribed mupirocin ointment to use on the affected area.The skin area healed.
Additional Manufacturer Narrative
Method and results codes updated to reflect analysis findings.A review of the returned bandages found no visible foreign matter, defects, or damage to the bandages or cold seal packaging.The product's 2-year complaint history was reviewed for the reported product lot # and failure code.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.End of report.

• Brand Name: NEXCARE(TM) WATERPROOF BANDAGES
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• MDR Report Key: 9180383
• Report Number: 2110898-2019-00117
• Device Sequence Number: 11453732
• Product Code: KGX
• UDI-Device Identifier: 00051131199354
• UDI-Public: 00051131199354
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 01/02/2020

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: 588-20PB
• Device Lot Number: 19136M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 01/02/2020
• 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