BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPD 60000 RPM

    MDR report key: 3575758 · Received January 15, 2014

    Report

    Report Number
    8030965-2014-00060
    Event Type
    Malfunction
    Date Received
    January 15, 2014
    Date of Event
    December 4, 2013
    Report Date
    December 18, 2013
    Manufacturer
    SYNTHES, USA
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS. PRODUCT CODE: DZI, ERL, HBE. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS IN ONGOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE ELECTRIC PEN DRIVE RUNS BY ITSELF AND DOES NOT STOP. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40652 EPD 60000 RPM HWE SYNTHES, USA SER.NO. 3883

    Patients

    Seq Age Sex Outcome Treatment
    1