BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX TOBRAMYCIN 1 PK

    MDR report key: 2925159 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00090
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    November 13, 2012
    Report Date
    January 3, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. MEDICAL RECORD REVIEW WAS NOT PERFORMED BECAUSE IT WAS REPORTED THAT THERE WAS NO DELAY IN SURGERY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES. THE EVENT WAS CONFIRMED. VISUAL INSPECTION CONFIRMED THAT THE FOREIGN MATERIAL IS A PIECE CARDBOARD. THE INVESTIGATION CONCLUDED THAT FOREIGN MATERIAL IS A PIECE OF CARDBOARD. AS THE POWDER POUCH WAS RETURNED OPENED IT CANNOT BE DETERMINED IF THE CARDBOARD WAS PRESENT WITHIN THE OUTER POUCH PRIOR TO OPENING OF THE POUCH.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ITEM WAS OPENED AND ALLEGEDLY A FOREIGN OBJECT WAS NOTICED IN THE STERILE PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ITEM WAS OPENED AND ALLEGEDLY A FOREIGN OBJECT WAS NOTICED IN THE STERILE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29762 SIMPLEX TOBRAMYCIN 1 PK NA LOD STRYKER ORTHOPAEDICS-MAHWAH TET037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other