BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATT-HANDPIECE MOD F/TRS

    MDR report key: 3083339 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-02025
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    March 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED. DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE BUTTONS ON THE BATTERY HANDPIECE/MODULAR ARE FUNCTIONLESS. THE DEVICE WAS RETURNED TO THE CUSTOMER AFTER REPAIR. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183299 BATT-HANDPIECE MOD F/TRS GEY SYNTHES GMBH SER. NO. 6388

    Patients

    Seq Age Sex Outcome Treatment
    1