BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KMEDIC ORTHO. MALLET 3 LB/2 LB

    MDR report key: 2588532 · Received May 21, 2012

    Report

    Report Number
    3005236665-2012-00005
    Event Type
    Malfunction
    Date Received
    May 21, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 3, 2012
    Manufacturer
    KMEDIC EUROPE GMBH
    Product Code
    HXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: "CUSTOMER CALLED SAYING THAT DURING A CASE, THE HEAD OF THE MALLET BROKE OFF OF THE HANDLE. NO PIECES FELL INTO THE PATIENT AND THERE WAS NO PATIENT INJURY." PATIENT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KMEDIC ORTHO. MALLET 3 LB/2 LB MALLET HXL KMEDIC EUROPE GMBH 98/2

    Patients

    Seq Age Sex Outcome Treatment
    1