BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUTIMED

    MDR report key: 12843338 · Received November 19, 2021

    Report

    Report Number
    12843338
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 12, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BSN MEDICAL INC.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    RN ATTEMPTED TO PEEL OFF PAPER BACKING OFF OF ADHESIVE PERFORATED FOAM FROM TOTAL CONTACT CAST KIT. PAPER BACKING WAS STICKING TO FOAM AND WAS NOT EASILY REMOVABLE. A SECOND TOTAL CONTACT CAST KIT HAD TO BE OPENED IN ORDER TO GET A NEW ADHESIVE PERFORATED FOAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741302 CUTIMED DRESSING, WOUND, DRUG FRO BSN MEDICAL INC. 2114, 2111

    Patients

    Seq Age Sex Outcome Treatment
    1 21900 DA Male