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 Dyspnea (1816); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 09/07/2022

Event Type  Injury  

Event Description

A female customer (age unspecified) reported an incident regarding her 11-year-old daughter.She had a tumor removed from her right knee on (b)(6) 2022.The morning of (b)(6), 2022, after the hospital bandage was removed, they applied the nexcare clear waterproof bandages on the area.On the same day (after an unspecified period), she got a call from her school regarding an allergic reaction (swelling and hives) to the bandage.The mother took her to the emergency room (er) from school because she developed dyspnea (difficulty breathing).At the er, they prescribed her benadryl and an unspecified steroid.The alleged reaction resolved the same day.No allergies, medical history or intervention reported.

Manufacturer Narrative

The product has a 5 year shelf life claim.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.

• 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: 15667513
• MDR Text Key: 302358198
• Report Number: 2110898-2022-00113
• 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: 10/20/2022

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: 10/10/2022
• Initial Date FDA Received: 10/25/2022
• 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 Age: 11 YR
• Patient Sex: Female
• Patient Race: White