MAUDE Adverse Event Report: TOP CARE WATERPROOF STRONG STRIPS; BANDAGE, ELASTIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Wound Dehiscence (1154)

Event Date 05/29/2019

Event Type  Injury  

Event Description

Husband is diabetic and been trying to resolve very small wound on big toe.One of the things being used was bandaids/bandages to cover wound with various meds under them.Supposed to cover with bandaids / bandages.The top care brand has benzalkonium chloride in between 2 pads, and this has exacerbated the wound which had been healing.It is not the only bandaid / bandages using this either, it is almost impossible in this county to not find that, or some sort of infection control within the pad that is to be against wound."i also used one of these on a blister caused by rubbing of thong top." and they made my sore area bigger and worse.

• Brand Name: TOP CARE WATERPROOF STRONG STRIPS
• Type of Device: BANDAGE, ELASTIC
• MDR Report Key: 8675496
• MDR Text Key: 147448135
• Report Number: MW5087180
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR