BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE CASING FOR 12V BATTERY

    MDR report key: 3130611 · Received May 24, 2013

    Report

    Report Number
    8030965-2013-02326
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HOME HEALTH AIDE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTS THE BATTERY CASING DOES NOT FUNCTION. THE FACILITY CONFIRMS DEVICE WAS USED IN AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE IN MARCH 2013. IT IS REPORTED THE PROCEDURE WAS NOT DELAYED AS A SPARE DEVICE WAS AVAILABLE AND WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231649 SMALL BATTERY DRIVE CASING FOR 12V BATTERY HWE SYNTHES GMBH 003870

    Patients

    Seq Age Sex Outcome Treatment
    1