BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 2540531 · Received April 10, 2012

    Report

    Report Number
    1314800-2012-00020
    Event Type
    Malfunction
    Date Received
    April 10, 2012
    Date of Event
    March 20, 2012
    Report Date
    April 5, 2012
    Manufacturer
    KAZ, INC.
    Product Code
    DXN
    PMA / PMN Number
    K050491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE CUFF OVERINFLATES WHICH CAUSED A BRUISE TO HIS ARM. KAZ USA HAS SENT A PRE-PAID LABEL TO RETRIEVE THE UNIT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN BLOOD PRESSURE MONITOR DXN KAZ, INC. BP4900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other