BEUDAMED
    FDA Adverse Event Other Summary report: N

    HARMONY PRS

    MDR report key: 455884 · Received April 25, 2003

    Report

    Report Number
    2182293-2003-00001
    Event Type
    Other
    Date Received
    April 25, 2003
    Date of Event
    March 27, 2003
    Manufacturer
    OTTO BECK HEALTH CARE, LP
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CAME FOR REPAIR OF PROSTHETIC DEVICE. THE PT INDICATED THAT WHILE AT A MOVIE THEATRE THE PROSTHETIC LEG FELL OFF DUE TO LACK OF VACUUM CAUSING PT TO FALL, SCRAPE THEIR KNEE, AND HIT THEIR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONY PRS PROSTHETIC SUSPENSION DEVICE ISY OTTO BECK HEALTH CARE, LP 4R134 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other