BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R+G

    MDR report key: 2980134 · Received February 21, 2013

    Report

    Report Number
    1526350-2013-00083
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO THE MFR; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER THAT THEY RECEIVED A BROKEN AMPOULE OF MONOMER IN A CASE OF PALACOS R=G BONE CEMENT. IT WAS REPORTED THAT THERE WAS A CONCERN THE FUMES WOULD BE HARMFUL. IT WAS NOTED THAT A STOCKROOM EMPLOYEE WAS IN AN AREA THAT WAS ADEQUATELY VENTILATED, BUT WAS NOT WEARING ANY PERSONAL PROTECTIVE EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76504 PALACOS R+G PALACOS R+G 1X 40G SINGLE WITH GENTAM LOD ZIMMER SURGICAL NA 75424316

    Patients

    Seq Age Sex Outcome Treatment
    1