BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE CEMENT

    MDR report key: 2032682 · Received March 17, 2011

    Report

    Report Number
    9610726-2011-00079
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "A MATERIALS MANAGEMENT EMPLOYEE WAS ON THE RECEIVING DOCK IN ORDER TO BRING THE HOSPITAL SHIPMENT TO THEIR RESPECTIVE DEPARTMENTS. THERE WAS AN ODOR COMING FROM A BOX. THE BOX WAS A GENERIC BOX WITH A STRYKER ADDRESS ON IT. IT DID NOT HAVE A HAZARDOUS MATERIALS LABEL ON IT. THERE WAS A UPS LABEL TO (B)(6) ON THE BOX. WHEN THE (B)(6) OPENED THE BOX, HE WAS BOTHERED BY THE VAPORS. HE SAID IT BOTHERED HIS RESPIRATORY SYSTEM, EYES AND NOSE. HE, THEREFORE, WENT TO CORPORATE HEALTH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE CEMENT CEMENT LOD STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other