BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWTRON

    MDR report key: 292095 · Received August 24, 2000

    Report

    Report Number
    2431480-2000-00410
    Event Type
    Injury
    Date Received
    August 24, 2000
    Report Date
    August 24, 2000
    Manufacturer
    HUNTLEIGH HEALTHCARE, INC.
    Product Code
    JFA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 7/27/00 INITIAL RPTR REC'D REPORT FROM HOSPITAL ORTHOPEDIST THAT ALLEGED THAT TWO PATIENTS EXPERIENCED COMPLICATIONS WHILE ON THE HUNTLEIGH EXTERNAL PNEUMATIC COMPRESSION SYSTEM: ONE (1) PULMONARY EMBOLISM AND ONE (1) PERONEAL NERVE PALSY.

    Description of Event or Problem · 2

    ON 7/27/00 INITIAL RPTR REC'D REPORT FROM HOSP ORTHOPEDIST THAT ALLEGED THAT TWO PATIENTS EXPERIENCED COMPLICATIONS WHILE ON THE HUNTLEIGH EXTERNAL PENUMATIC COMPRESSION SYSTEM: ONE (1) PULMONARY EMBOLISM AND ONE (1) PERSONEAL NERVE PALSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOWTRON EXTERNAL PNEUMATIC COMPRESSION SYSTEM JFA HUNTLEIGH HEALTHCARE, INC. AC550-GARMENT UNKNOWN 510(K)#: K961166

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN
    2 UNKNOWN