MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE ABSOLUTE WATERPROOF TAPE; TAPE AND BANDAGE, ADHESIVE

Model Number	731
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Skin Irritation (2076)
Date of Event	06/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's demographic: information was not provided.No sample has been returned to 3m for evaluation.Root cause of reported issue could not be established.The 2 year complaint history was reviewed for product's global sales code of syb and lot number 20133j.Review of complaint history found no trends.3m will continue to monitor.
Event or Problem Description
A male customer first applied the referenced tape in two crossing strips over his twisted knee on (b)(6) 2020.The tape was removed that same evening, reportedly with no issues.The customer applied the tape again around his knee the evening of (b)(6) 2020.The customer alleged that the tape was removed the following morning due to him experiencing itching and skin redness.A big blister allegedly developed above his knee.Two additional blisters later developed on his knee and one below.The blisters reportedly measured approximately.5"-1" in width.The customer reported allergies to compounds with organic mercury.No other known allergies were specified.The customer reported that the reaction looked similar to allergic reactions he experienced in the past.He applied a cool damp washcloth on the skin areas and elevated his leg.The customer visited a doctor on (b)(6) 2020.The doctor reportedly diagnosed the affected skin area as hives.The doctor prescribed an unspecified topical ointment to be applied twice daily and recommended the customer take otc zyrtec®.The customer also took otc benadryl® to treat symptoms.

• Brand Name: NEXCARE ABSOLUTE WATERPROOF TAPE
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul, mn
• MDR Report Key: 10307553
• Report Number: 2110898-2020-00036
• Device Sequence Number: 10977769
• Product Code: KGX
• UDI-Device Identifier: 00051131199385
• UDI-Public: 00051131199385
• 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): 07/22/2020

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: 731
• Device Catalogue Number: 731
• Device Lot Number: 20133J
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/22/2020
• 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: Required Intervention