BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US TOBRA FD 10-PK

    MDR report key: 4210955 · Received October 29, 2014

    Report

    Report Number
    0002249697-2014-04047
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A SIMPLEX PACKAGING WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THERE WAS NO PATIENT INVOLVEMENT. -DEVICE HISTORY REVIEW: REVIEW OF THE BATCH MANUFACTURING RECORD INDICATES THAT THIS BATCH WAS MANUFACTURED AND SHIPPED TO STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: REVIEW DETERMINED THAT THERE WERE NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT. CONCLUSIONS: THE EVENT WAS NOT CONFIRMED AS NO DEVICES OR PHOTOGRAPHS WERE PROVIDED FOR REVIEW. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THERE WAS AN ODOUR COMING FROM THE PRODUCT WHEN THE REPORTED DAMAGE WAS NOTED. THIS INDICATES THAT AN AMPOULE(S) WAS BROKEN AT THE TIME OR SHORTLY BEFORE THE PRODUCT WAS RECEIVED BY THE CUSTOMER AS THE SMELL WOULD HAVE COME FROM THE MONOMER WHEN THE AMPOULE WAS BROKEN. THIS ODOUR FROM THE MONOMER LIQUID LASTS A SHORT PERIOD OF TIME AS THE LIQUID EVAPORATES WHEN EXPOSED TO THE ATMOSPHERE. BASED ON THE INFORMATION PROVIDED, IT APPEARS THAT THIS PRODUCT WAS DAMAGED DUE TO INAPPROPRIATE HANDLING DURING DISTRIBUTION/TRANSPORTATION.

    Description of Event or Problem · 1

    THE PURCHASING AGENT REPORTED THAT THE HOSPITAL RECEIVED DAMAGED PRODUCT. THE OUTER PACKAGING WAS NOT DAMAGED BUT THERE WAS A DISTINCT ODOR TO THE BOX.

    Description of Event or Problem · 1

    THE PURCHASING AGENT REPORTED THAT THE HOSPITAL RECEIVED DAMAGED PRODUCT. THE OUTER PACKAGING WAS NOT DAMAGED BUT THERE WAS A DISTINCT ODOR TO THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691942 SIMPLEX P - US TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH MDV032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other