MAUDE Adverse Event Report: FABRIC BANDAGES; TAPE AND BANDAGE, ADHESIVE

Lot Number 00142036

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

Patient Problems Bruise/Contusion (1754); Erythema (1840); Skin Disorders (4543)

Event Date 06/16/2021

Event Type  Injury  

Event Description

With multiple uses of the bandages on different body parts this occurred to varying degrees, but always something happened.This occurred where the adhesive was in each case.The bandages left mild-severe red marks that stayed for a long time, especially the outline of the bandage.There was occasionally bruising at the end of the bandage after removal.On some healthy skin when the bandage was removed there was flaky white skin.One bandage ripped off a decent size chunk of skin.(b)(6).Safety report id# (b)(4).

• Brand Name: FABRIC BANDAGES
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 12161094
• MDR Text Key: 261686202
• Report Number: MW5102512
• Device Sequence Number: 1
• Product Code: KGX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 00142036
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1