BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE

    MDR report key: 3973070 · Received April 29, 2014

    Report

    Report Number
    8031000-2014-00233
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP 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 WORKED WITHOUT BEING OPERATED. THIS OCCURRED DURING KIT INSPECTION AND THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255567 UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE GEY ZIMMER SURGICAL S.A. NA 207473

    Patients

    Seq Age Sex Outcome Treatment
    1