BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT CONTROL

    MDR report key: 3811836 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-05270
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    September 3, 2012
    Report Date
    September 17, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS NOT WORKING. THE DEVICE WAS BEING USED DURING EAR, NOSE, AND THROAT (ENT) SURGERY. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524599 FOOT CONTROL MOTOR, DRILL, ELECTRIC - FOOT CONTROL HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1