BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIBLE FABRIC EXTRA-LARGE BANDAGES

    MDR report key: 14855651 · Received June 28, 2022

    Report

    Report Number
    MW5110593
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    June 22, 2022
    Report Date
    June 26, 2022
    Manufacturer
    UP&UP (TARGET BRAND) / TARGET GENERAL MERCHANDISE INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED AND USED TARGET BRAND "UP&UP" FLEXIBLE FABRIC EXTRALARGE BANDAGES - 10 COUNT WITH CODES 245 07 0727 R01, IDC-000450-01-037, (B)(4) ON BOX. THE BANDAGES HAVE AN ADHESIVE WHICH IS TOO AGGRESSIVE AND RIPPED THE SKIN OFF MY ARM. I SAVED SOME OF THE BANDAGES AND A BOX IF THE FDA WANTS TO TEST IT. I HAVE PHOTOS AS WELL. I USED THE PRODUCT AS DIRECTED ON DRY SKIN. FDA SAFETY REPORT ID# (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383421 FLEXIBLE FABRIC EXTRA-LARGE BANDAGES TAPE AND BANDAGE, ADHESIVE KGX UP&UP (TARGET BRAND) / TARGET GENERAL MERCHANDISE INC. 245 07 0727 R01 00161937

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose VASELINE