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	Abrasion (1689)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product shelf life is 5 years from the date of manufacture.The product was returned by the consumer and analyzed.Bandage samples and primary carton were received.A visual inspection of the returned samples found no notable foreign matter, defects, or damage to bandages or cold seal packaging.The complaint history was reviewed for the past 24 months for product global sales code (sxj) and defined failure code.No trends were observed.A search of complaints for the reported product lot number 18289m found no additional complaints with the reported 3m global sales code and lot number combination.3m will continue to monitor.
Event or Problem Description
A female consumer (age not specified) applied the referenced bandages to cover two small wounds on her right hand between her wrist and fingers.Prior to application, the consumer washed her hands with antibacterial soap and allowed them to dry.The consumer also applied a smaller sized referenced bandage over a small wound on her left hand.The bandages were applied on (b)(6) 2019 and worn for approximately 5-6 hours.The consumer reported the bandages were difficult to remove.The consumer repeatedly pulled the bandage corners up to remove.During removal, the consumer alleged the bandages removed three large spots of skin on her right hand.She reported the spots occurred at the bandage adhesive location.During the removal of the smaller bandage, the consumer alleged one skin area on her left hand was removed.She reported the affected areas looked raw and bled.The consumer cleaned the affected areas and applied manual pressure to stop the bleeding.The consumer reported she is a diabetic and visited her doctor on (b)(6) 2019, due to the affected areas starting to look red.The doctor prescribed an unspecified antimicrobial cream and an antibiotic, cephalexin 500mg.On (b)(6) 2019, the consumer reported the affected areas were still a little red, however, drying up.

• 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: 8565714
• Report Number: 2110898-2019-00058
• Device Sequence Number: 3020164
• 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
• Report Date (Section B): 04/30/2019

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 Expiration Date: 10/16/2023
• Device Model Number: N/A
• Device Catalogue Number: 588-20PB
• Device Lot Number: 18289M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/30/2019
• 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
• Patient Age: 51 YR