BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KMEDIC WILDE IVD RONG. 5" STR. 6X11MM

    MDR report key: 3072658 · Received April 19, 2013

    Report

    Report Number
    3005236665-2013-00003
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 27, 2013
    Manufacturer
    KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE HAS NOT BEEN RECEIVED BY MANUFACTURER IN TIME FOR THIS REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: COMPLAINT ALLEGES: PRODUCT WAS BEING USED TO REMOVE A SMALL BONE CHIP IN FETLOCK JOINT BY THE VETERINARIAN. THE INSTRUMENT BROKE IN THE PROCESS. THERE WAS NO EXCESSIVE FORCE USED IN THE PROCEDURE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169812 KMEDIC WILDE IVD RONG. 5" STR. 6X11MM SPINAL CUSHING IVD RONGEUR HAE KMEDIC GMBH, PILLING WECK, TELEFLEX MEDICAL 07/1

    Patients

    Seq Age Sex Outcome Treatment
    1