BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT CONTROL

    MDR report key: 3983861 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16127
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY DUPUY SYNTHES POWER TOOLS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE USA, STATING THAT THE DEVICE DOES NOT FUNCTION. THE DEVICE WAS BEING USED DURING SURGERY. THERE ALSO WAS NO REPORT OF USER OR PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663259 FOOT CONTROL HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1