BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R+G

    MDR report key: 3853633 · Received April 3, 2014

    Report

    Report Number
    1526350-2014-00245
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 3, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PALACOS R+G 1X 40G SINGLE (WITH GENTAMICIN) PACKAGE WAS NOT ABLE TO BE OPENED WITH STERILE TECHNIQUE. INTEGRITY OF INNER POUCH WAS COMPROMISED FROM THE FACTORY. THERE WAS A TEAR IN THE INNER POUCH. THERE WAS NO PT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203065 PALACOS R+G PALACOS R+G 1X 40G SINGLE (WITH GENTAMICIN) LOD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1