BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R+G

    MDR report key: 3915831 · Received June 12, 2014

    Report

    Report Number
    1526350-2014-00378
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR EVAL. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN OPENING THE POUCH THAT CONTAINS THE STERILE PACK OF PALACOS R+G POWDER, THE TWO PIECES THAT ARE GLUED TOGETHER (ONE CLEAR/ONE WHITE), TEAR IMPROPERLY, POSSIBLY CONTAMINATING THE STERILE POUCH. THE REPORTED EVENT OCCURRED DURING THE SURGERY AFTER THE PACKAGES WERE OPENED. THE PRODUCT WAS DISCARDED AND AN ALTERNATE DEVICE WAS OPENED TO COMPLETE THE SURGERY. THERE WAS NO HARM OR DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346568 PALACOS R+G PALACOS R+G 1X 40G SINGLE LOD ZIMMER SURGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1