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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Discoloration (2074); Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Patient age or date of birth, weight, ethnicity: information not provided.Date of event: not reported.The product has a 3 year shelf life claim.Lot# - not provided.Lot# not provided.Therefore, unable to determine manufacture date.No sample has been received for analysis.The 2-year complaint history was reviewed for the product's global sales code (gsc) of sxj and reported failure.No trends were observed.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.End of report.

Event Description

A female customer (age unspecified) reported an incident regarding the nexcare waterproof bandages.On an unspecified date, she applied the bandage on the medial back of her right leg covering a small cut that was bleeding.She washed the area with soap and water before the bandage was placed.She had no idea how long the bandage was in place.On an unspecified the date, she noticed her leg turned brown.The bandage was allegedly difficult to remove.She tried removing with olive oil, adhesive removal wipe she got from the doctor, and she tried picking at it.She was able to remove most of the adhesive but was unable to get it all off.On an unspecified date, she used the tip of the scissors and tweezers to remove the bandage.She alleged the area was irritated from picking at it.The area was allegedly 1" in size, and it got infected.The alleged injury is in the same shape as the bandage.She alleged she must not have removed all the adhesive from the bandage because when she visited the doctor for a growth on her leg, the doctor stated that there were adhesive on the area (exact location and dates were not reported).On (b)(6) 2022, she went to the dermatologist.She allegedly had an infection and the doctor had to remove the infected area.She plans to go back to the doctor on (b)(6) 2022.No allergies or medical history reported.

• Brand Name: NEXCARE¿ WATERPROOF BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY; 905 adams street se; hutchinson MN 55350
• Manufacturer Contact: bryan becker ; 2510 conway avenue; st. paul, MN 55144 ; 6517375578
• MDR Report Key: 15545122
• MDR Text Key: 301206637
• Report Number: 2110898-2022-00100
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 5113199524
• UDI-Public: 5113199524
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2022

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
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 588-20PB
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White