BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEER STRIPS

    MDR report key: 13542060 · Received February 15, 2022

    Report

    Report Number
    MW5107470
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    February 9, 2022
    Report Date
    February 10, 2022
    Manufacturer
    UNK
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    COVER ON ADHESIVE DEFECTIVE; EQUALINE [(B)(4)] SHEER STRIPS XL ADHESIVE BANDAGES. COVERS ON GAUZE PART DO NOT STRIP AWAY. CRUMBLES INTO PIECES WHICH ADHERE TO THE ADHESIVE PARTS. NOT SUITABLE FOR THE INTENDED USE AS A CLASS 1 MEDICAL DEVICE. UPC 0 41163 24468 9 EQUALINE, BOUGHT FROM OSCO IN (B)(6) IN 2021. (B)(6) IS A CHILD OF PARENT (B)(4). BOX OF 10 "SHEER STRIPS" STATES, "WE ARE COMMITTED TO YOUR SATISFACTION AND GUARANTEE THE QUALITY OF THIS PRODUCT. CONTACT US AT (B)(4), OR WWW.ALBERTSONS.COM. VIOLATION OF SECTION 502 FD&C ACT SECTION 502 MISBRANDING. DISTRIBUTED BY (B)(4). FDA SAFETY REPORT ID #:(B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173098 SHEER STRIPS TAPE AND BANDAGE, ADHESIVE KGX UNK EXTRA LARGE 243125

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other