BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC 2POUND/1POUND MALLET

    MDR report key: 3537202 · Received October 21, 2013

    Report

    Report Number
    3005236665-2013-00008
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 1, 2013
    Manufacturer
    KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL GERMANY
    Product Code
    GFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE HAS BEEN RECEIVED BY MANUFACTURER, BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: COMPLAINT ALLEGES: "AFTER FOUR MONTHS THE CONDITION AND SHAPE OF THE MALLETS HAVE DEFORMED, AND BITTED AROUND THE EDGES OF THE MALLET HEADS. CONCERNED CUSTOMER MENTIONED THAT SOME BITS OF THE MALLETS MAY HAVE FALLEN INSIDE THE PATIENT HOWEVER THERE HAS BEEN NO REPORTS OF THIS". THERE WAS NO MEDICAL INTERVENTION. PATIENT CONDITION LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539548 ORTHOPEDIC 2POUND/1POUND MALLET ORTHOPEDIC MALLET GFJ KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL GERMANY B0

    Patients

    Seq Age Sex Outcome Treatment
    1