BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVECARE DVT SYSTEM

    MDR report key: 695293 · Received March 30, 2006

    Report

    Report Number
    9616558-2006-00001
    Event Type
    Death
    Date Received
    March 30, 2006
    Date of Event
    January 2, 2006
    Report Date
    March 15, 2006
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT WITH DR'S PATIENT OCCURRED IN 2006. PROCEDURE WAS A SURGICAL ABDOMINAL PLASTY, LIPO, AND BILATERAL BREAST AUGMENTATION. PT. ADMITTED ON 1/2006 @7:12AM INTO OR 9:26AM WITH ACTIVE CARE LEG DEVICE ON THROUGHOUT PROCEDURE AND HOSPITAL STAY. SHE WAS DISCHARGED THAT AFTERNOON AT 15:55. PT WAS PREPARING TO DRESS TO LEAVE. THIS PATIENT COMPLICATION STATED BY DR. WAS A P.E. AND WAS RE HOSPITALIZED. NO DEATH, NO KNOWN OTHER FACTS". "ACCOUNT CLINICAL DIRECTOR, CYNTHIA MIRANDA, STATED THAT DOCTOR ALLEGED THAT A PATIENT UTILIZED AN ACTIVE CAR DVT WHILE AT THE HOSPITAL. DOCTOR KINSLEY THEN ALLEGED THAT THE PATIENT EXPIRED IN HER HOME, 7 DAYS AFTER BEING RELEASED FROM THE HOSPITAL. DOCTOR ALLEGED THAT THE ACTIVE CARE DVT CONTRIBUTED TO THE PATIENT EXPIRING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVECARE DVT SYSTEM COMPRESSIBLE LIMB SLEEVE JOW MEDICAL COMPRESSION SYSTEMS (DBN) LTD. ACTIVECARE DVT SYST NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death