BEUDAMED
    FDA Adverse Event Other Summary report: N

    DAVOL ARTHRO FLO REGULATOR

    MDR report key: 35683 · Received June 28, 1996

    Report

    Report Number
    35683
    Event Type
    Other
    Date Received
    June 28, 1996
    Date of Event
    May 31, 1996
    Report Date
    June 19, 1996
    Manufacturer
    DAVOL, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR INTERNAL DERANGEMENT RIGHT KNEE, POSSIBLE TEAR MEDIAL MENISCUS. VIDEO ARTHROSCOPY PERFORMED. POST-OP PT HAD SIGNIFICANT PROBLEMS REGARDING DISTENSION OF THIGH AND/OR KNEE. ETIOLOGY DUE TO POOR PRESSURE REGULATION ON INFLOW PRESSURE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL ARTHRO FLO REGULATOR ARTHRO FLO REGULATOR HRX DAVOL, INC. 3776 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other