BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    400ML COMPACT EVACUATOR COMPONENT KIT

    MDR report key: 3010851 · Received March 14, 2013

    Report

    Report Number
    1526350-2013-00127
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 13, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR 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 ZIMMER 400ML COMPACT EVACUATOR WAS CRACKED. THE INCIDENT WAS NOTED PRIOR TO USE AND THERE WAS NO REPORT OF HARM TO THE PT. THIS REPORT IS BEING REPORT ALONG WITH 1526350-2013-00128.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108438 400ML COMPACT EVACUATOR COMPONENT KIT 400ML COMPACT EVACUATOR COMPONENT KIT GCY ZIMMER SURGICAL NA 62188105

    Patients

    Seq Age Sex Outcome Treatment
    1