BEUDAMED
    FDA Adverse Event Other Summary report: N

    PULSTAR PAS II ANTI EMBOLISM SYSTEM

    MDR report key: 330353 · Received May 2, 2001

    Report

    Report Number
    1043612-2001-00001
    Event Type
    Other
    Date Received
    May 2, 2001
    Date of Event
    March 8, 2001
    Report Date
    May 1, 2001
    Manufacturer
    ALBAHEALTH DIV. OF ALBA-WALDENSIAN, INC.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER HOSPITAL'S REPORT "PT UNDERWENT RIGHT LEG SYRGERY ON 03/2001. PT'S LEG WAS PLACED ON AN ABDUCTION PILLOW AND WAS FITTED WITH A SEQUENTIAL COMPRESSION DEVICE. NOTHING IS CHARTED TO INDICATE ANY PROBLEMS WITH NEUROVASCULAR CHECKS WHILE THE PT WAS IN THE ORTHOPEDIC UNIT THE DAY OF THE SURGERY. THE MDR NOTED THE FOLLOWING MORNING THAT THE PT HAD SUFFERED "RIGH FOOT DROP". HOSPITAL DID NOT RESPOND TO REQUESTS FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20397 PULSTAR PAS II ANTI EMBOLISM SYSTEM PULSATILE ANTI-EMBOLISM SYSTEM JOW ALBAHEALTH DIV. OF ALBA-WALDENSIAN, INC. PAS II 30401077

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization ABDUCTIION PILLOW - NO PACKAGING AVAILABLE.