MAUDE Adverse Event Report: 3M HEALTH CARE NEXCARE¿ ACTIVE¿ WATERPROOF BANDAGES, KNEE AND ELBOW; 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	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This information was not provided.Lot # was not provided, therefore expire date unknown.Waterproof bandages have a 5 years shelf life.Occupation: initial reporter's occupation was not specified.Lot # was not provided, therefore manufacture date is unknown.The device has been not returned for evaluation, though requested by 3m.Product lot # was not provided.Complaint history was reviewed for the past 24-month period for the reported failure code and the product's global sales code of szr.No statistical trends were observed.3m will continue to monitor.The product will be evaluated and a follow up report will be submitted if product is received.End of report.
Event or Problem Description
A (b)(6) african-american male consumer reported he underwent a recent cyst removal procedure.The consumer purchased and applied the referenced bandages to cover the chest incision wound on (b)(6) 2019.The consumer's doctor recommended the incision be kept dry.Prior to application, the incision area was washed with (b)(6) soap and (b)(6) was applied.The bandages used were changed twice daily, in the morning and night.Each bandage was worn for approximately 12 hours.A total of 4 bandages were worn over the course of two days.The first bandage was applied post-procedure, later in the day.The bandage was removed the next day.The consumer alleged he noticed a little red mark on his skin at this time.The consumer reported no known allergies.After removal of the fourth bandage, on second day of wear, the consumer alleged his skin became red, scaly, itchy, and started to darken.He reported the reaction was in the shape of the bandage.The consumer reported difficulty removing the bandages worn.On (b)(6) 2019, the consumer visited his doctor to have stitches removed.The consumer reported a pa prescribed hydrocortisone cream 2% to use on the affected area for 7 days.The consumer is also applying otc ambi fade cream.The pa advised the consumer he may experience some skin discoloration on his middle chest.On (b)(6) 2019, the consumer reported the affected area no longer had a "scaly" appearance after 3 days of hydrocortisone cream 2% use.The consumer has an appointment (b)(6) 2019 with a dermatologist to re-evaluate the affected area.

• Brand Name: NEXCARE¿ ACTIVE¿ WATERPROOF BANDAGES, KNEE AND ELBOW
• Common Device Name: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• MDR Report Key: 8516185
• Report Number: 2110898-2019-00043
• Device Sequence Number: 11243287
• Product Code: KGX
• UDI-Device Identifier: 00051131208179
• UDI-Public: 00051131208179
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 511-08
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/15/2019
• 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: 58 YR