BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3810798 · Received March 21, 2014

    Report

    Report Number
    8031000-2014-00185
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 4, 2014
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE GOT REALLY HOT AND THE BATTERY WAS DISCHARGING REALLY FAST. THERE WAS NO HARM OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169832 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUB GFA ZIMMER SURGICAL S.A NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1