BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL ASEPTIC TRANSFER KIT HOUSING

    MDR report key: 3123980 · Received May 15, 2013

    Report

    Report Number
    8031000-2013-00035
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL ASEPTIC TRANSFER KIT HOUSING DID NOT HAVE ANY PRESSURE AND WAS OPENED WHILE THE HAND PIECE MOTOR WAS RUNNING. IT WAS REPORTED THAT SURGERY TIME WAS EXTENDED BY AN UNSPECIFIED AMOUNT OF TIME. THERE WAS NO REPORT OF PT INJURY ASSOCIATED WITH THE EVENT. NO ADD'L CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214667 UNIVERSAL ASEPTIC TRANSFER KIT HOUSING UNIVERSAL ASEPTIC TRANSFER KIT HOUSING MOQ ZIMMER SURGICAL S.A. NA 5001974

    Patients

    Seq Age Sex Outcome Treatment
    1