MAUDE Adverse Event Report: 3M NEXCARE BANDAGES; BANDAGE, LIQUID

Lot Number 15087B

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Unspecified Infection (1930); Scarring (2061); Reaction (2414)

Event Date 05/12/2017

Event Type  Injury  

Event Description

I used a nexcare bandaid on a cut and the bandaid burned my skin.Had an infection and now have a scar.Had to go to the emergency room twice as it was not getting better.I have contacted 3m-nexcare and they are not responding to me.I have given them everything they have asked for and they tell me they will call me back and they never do."is the product over-the-counter: yes; how was it taken or used: topical; did the problem stop after the person reduced the dose or stopped taking or using the product: no." dates of use: (b)(6) 2017.Reason for use: covering a cut.

• Brand Name: NEXCARE BANDAGES
• Type of Device: BANDAGE, LIQUID
• Manufacturer (Section D): 3M
• MDR Report Key: 6879496
• MDR Text Key: 86976391
• Report Number: MW5072239
• Device Sequence Number: 1
• Product Code: KMF
• UDI-Device Identifier: 5113199524
• UDI-Public: 5113199524
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: 15087B
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Other
• Patient Age: 60 YR