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 Codes	Itching Sensation (1943); Skin Irritation (2076)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model and serial # information not provided.Reporter's occupation was not provided.The device has not been returned by the customer to 3m for evaluation.Review of product's 2-year complaint history found no statistical trends.Complaints were also reviewed for reported product lot 16266j and found no other alleged injury complaints against this lot code.Without the product being returned from the customer for evaluation, root cause can't be determined at this time.Biocompatibility test results during product design confirm the biocompatibility of the 3m¿ nexcare¿ waterproof bandages for 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 reported she cut her left thumb on (b)(6) 2018, with a knife.She initially applied non-3m brand bandages to the cut as it healed.On (b)(6) 2018, the woman covered the cut with one of the referenced bandages.The bandage was removed, without difficulty, after 36 hours of wear.During the morning of (b)(6) 2018, a second bandage was applied to the wound area after showering.No topical ointment was applied to the cut.The bandage was worn for 48 hours.The woman alleged when she woke up the morning of (b)(6) 2018, her thumb was hurting.The woman alleged she attempted to remove the bandage by hand, but had difficulty.The bandage was removed using scissors.Upon removal, she alleged her thumb wound area was red, burning, and itchy.Neosporin was applied to the area.No known allergies were specified.During that same evening, she alleged feeling like a blister was forming.She alleged her thumb throbbed and was painful.The woman alleged discovering a blister formed, just below her nail bed and on her thumb pad, the morning of (b)(6) 2018.She alleged her skin in the area looked red and the blisters were somewhat yellow in color.She alleged experiencing some itchiness below the nail bed.She reported the throbbing sensation made it difficult to use her thumb.The woman visited a doctor, that same day, and was prescribed clindamycin hcl300mg.On (b)(6) 2018, the woman reported her thumb had a lot of puss in it.She reported her thumb was still very painful, but seemed to be getting better since starting the antibiotic.The woman reported her doctor did not specify what caused her symptoms, but advised an infection occurred.

• 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: 8209868
• Report Number: 2110898-2019-00001
• Device Sequence Number: 207618
• Product Code: KGX
• UDI-Device Identifier: 00051131199354
• UDI-Public: 00051131199354
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/02/2019

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: 09/22/2021
• Device Model Number: N/A
• Device Catalogue Number: 588-20PB
• Device Lot Number: 16266B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 01/02/2019
• 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