BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P FULL DOSE 1 PACK

    MDR report key: 1491587 · Received July 29, 2009

    Report

    Report Number
    9610726-2009-00151
    Event Type
    Malfunction
    Date Received
    July 29, 2009
    Date of Event
    July 7, 2009
    Report Date
    July 7, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    N17004
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "POWDER IN PACKAGE WAS NOT PACKAGED STERILE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P FULL DOSE 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA RHO191

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other