BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAD 1" FLEX-FABRIC STRIPS

    MDR report key: 805255 · Received January 12, 2007

    Report

    Report Number
    MW1041634
    Event Type
    Malfunction
    Date Received
    January 12, 2007
    Date of Event
    January 1, 2006
    Report Date
    January 12, 2007
    Manufacturer
    BEIERSDORF INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CURAD BANDAGE MANUFACTURED IN SUCH A WAY AS TO MINIMIZE THE ODDS OF MAINTAINING THE STERILITY OF THE PRODUCT WHEN IT IS APPLIED. APPLICATION TABS OFF SET FROM NORMAL POSITION, ATTEMPTS TO REMOVE TABS IN NORMAL MANNER RESULT IN UNINTENDED PREAPPLICATION CONTACT WITH STERILE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURAD 1" FLEX-FABRIC STRIPS BANDAGE KGX BEIERSDORF INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR