BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 2070702 · Received April 18, 2011

    Report

    Report Number
    2520274-2011-00118
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    January 28, 2011
    Report Date
    April 8, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. UNABLE TO PROVIDE THE MFR, PMA/510K NUMBER, AND/OR THE DATE OF MFR AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    THE NURSE CASE MANAGER REPORTED ON BEHALF OF A PT. PT HAD A REACTION AND DEVELOPED A RASH OVER MUCH OF HIS BODY, INFECTION DISEASE DID NOT THINK IT WAS (B)(6), BUT AN ALLERGIC REACTION TO SOMETHING. PARTS WERE 316L PRODUCT NUMBERS. IT WAS ALSO MENTIONED PT HAS TWO BROKEN SCREWS AT THE END OF HIS TIBIA. PT WAS IMPLANTED ON (B)(6) 2010, AND SCREWS WERE DISCOVERED BROKEN ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI SCREW HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI