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	Skin Irritation (2076); Injury (2348)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, race: information not provided.Product lot # was not provided.Waterproof bandages have a 5-year established shelf life.Reporter's occupation was not provided.The device has not been returned to 3m for evaluation.Product lot # was not provided, therefore manufacture date is unknown.Review of the product's 2-year complaint history for the reported failure code and the product's global sales code (sxj) found no statistical trends.Without the product being returned for evaluation, root cause can't be determined.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.
Event or Problem Description
A (b)(6)-year-old hispanic female consumer applied the referenced bandage to cover a biopsy wound on the front of her left arm, above the elbow.Prior to application, the wound area was washed with an antibacterial soap and allowed to dry.Two different types of nexcare¿ bandages were reportedly used, soft n flex and the waterproof bandages for use in the pool.The bandages were changed twice a day, alternating between the two types.The bandage application site was reportedly rotated during changes.The bandages were typically worn for 4-6 hours.The consumer reported she experienced pain while removing the bandages on the 2nd day of wear.On the 3rd day of wear, she alleged two layers of skin were pulled off during the removal of a nexcare¿ waterproof bandage.The consumer alleged a skin reaction occurred in the shape of the bandage adhesive.The affected area reportedly blistered.The consumer visited an urgent care.A doctor prescribed triamcinolone acetonide cream and an otc triple antibiotic ointment.Two weeks post-symptom onset the consumer reported the affected area had healed.She is continuing the prescribed treatment.
Additional Manufacturer Narrative
Added product lot #.Waterproof bandages have a 5-year established shelf life.Added device manufacture date.A primary of clear waterproof knee and elbow and soft n' flex knee and elbow were returned.A visual review of all returned bandages found no notable foreign mater, damage, or defects.Review of the product's 2-year complaint history for the reported failure code and the product's global sales code (sxj) found no statistical trends.3m will continue to monitor.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: 8897285
• Report Number: 2110898-2019-00094
• Device Sequence Number: 16551187
• Product Code: KGX
• UDI-Device Identifier: 00051131199361
• UDI-Public: 00051131199361
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/16/2019

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 Model Number: N/A
• Device Catalogue Number: 581-08
• Device Lot Number: 19007M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEXCARE¿ SOFT N FLEX BANDAGES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR