BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP

    MDR report key: 1230273 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00389
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSD
    PMA / PMN Number
    K041066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP HUMERAL SOCKET HSD ENCORE MEDICAL, L.P. 53946268

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LOT# 53944369| LOT# 53946713