BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEROFORM GAUZE DRESSING WITH 3% BISMUTH TRIBROMOPHENATE

    MDR report key: 12598286 · Received October 7, 2021

    Report

    Report Number
    MW5104474
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    August 23, 2021
    Report Date
    September 25, 2021
    Manufacturer
    DERMARITE INDUSTRIES, LLC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SEVERE PAIN, SKIN BLISTERING, INFLAMMATION, BURNING AND DISFIGURING OF SKIN AND EFFECT OF ANTIBIOTIC I WAS ON. AN INCORRECT DEVICE WAS SENT HOME FROM HALO WOUND SOLUTIONS, MY DOCTOR ORDERED AN ADAPTIC AND SCRIPT CORRECTLY AND PACKAGED THE WRONG ADAPTOR. THIS DEVICE WAS TO HELP WITH A WOUND ON MY ANKLE. I NOTIFIED HALO, MY DOCTOR AND MY PHARMACIST OF THE SEVERE AND PAINFUL REACTIONS I WAS EXPERIENCING. IT PROVIDES ALL THE INFORMED YOU NEED. I AM ALSO INCLUDING PHOTOS OF THE INJURIES SUFFERED AND ONGOING. PLEASE NOTE THERE WAS NO WARNING ON THE SINGLE PACKETS THAT THIS PRODUCT CAN BURN THE SKIN. I FOUND OUT AFTERWARDS THROUGH INTENSE RESEARCH ON THE INTERNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492805 XEROFORM GAUZE DRESSING WITH 3% BISMUTH TRIBROMOPHENATE DRESSING, WOUND, DRUG FRO DERMARITE INDUSTRIES, LLC. 24220 F-20210602

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R