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	Skin Tears (2516)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned by the consumer to 3m for evaluation.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.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.End of report.
Event or Problem Description
A (b)(6) year old, caucasian male consumer applied the referenced bandage to cover a bed sore on his left elbow on (b)(6) 2019.Prior to application, vitamin a&d ointment was applied on the sore.The bandage was removed the following morning, (b)(6) 2019.The man alleged a piece of his skin near the wound, approximately the size of.25 inches, was pulled off during removal.The affected area bled.The consumer reported he did not have sensitive or fragile skin.The affected area was flushed with cold water and the bleeding stopped.The consumer reported the wound later began to bleed again.He visited a doctor on (b)(6) 2019.The doctor prescribed bactrim ds (2x/day for 10 days) as a precaution to avoid infection.The consumer reported the wound stopped bleeding on (b)(6) 2019 and the affected area appeared to be healing.The consumer continued to apply neosporin and hydrogen peroxide onto the area and covered with a bandage.On (b)(6) 2019, the consumer reported the wound was almost completely healed.
Additional Manufacturer Narrative
A visual review of the returned bandages found no 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: 8822936
• Report Number: 2110898-2019-00090
• Device Sequence Number: 11383930
• Product Code: KGX
• UDI-Device Identifier: 00051131199361
• UDI-Public: 00051131199361
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 07/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/24/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 116