BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACTIVECARE +SFT HOMECARE

    MDR report key: 3240815 · Received July 17, 2013

    Report

    Report Number
    9616558-2013-00001
    Event Type
    Other
    Date Received
    July 17, 2013
    Date of Event
    February 1, 2013
    Report Date
    July 17, 2013
    Manufacturer
    MEDICAL COMPRESSION SYSTEMS
    Product Code
    JOW
    PMA / PMN Number
    K060146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCS IS NOT AWARE OF ANY PROBLEM WITH THE DEVICE. AFTER RECEIVING THE DEVICE FROM A PT, IT IS TESTED AND ONLY IF IT PASSES THIS TESTING, IT IS THEN HANDED OUT TO ANOTHER PT. THIS DEVICE WAS PASSED ON ACCORDING TO THIS REGULAR METHOD TO ANOTHER PT AND TO THE BEST OF OUR KNOWLEDGE IS WORKING PROPERLY. MCS REQUESTED DEVICE RETURN FOR INVESTIGATION BUT IT WAS NOT RETURNED BY ITS USER YET. AVAILABLE DATA SHOWS THAT THE DEVICE WAS USED BY THE COMPLAINING PT FOR FIVE DAYS POST DISCHARGE WITH A HIGH COMPLIANCE RECORDED BY THE SVC PROVIDER AT 91% (WELL WITHIN THE RECOMMENDATION FOR COMPLIANCE).

    Description of Event or Problem · 1

    MCS WAS NOTIFIED ON (B)(4) 2013 THAT THE PT'S WIFE REPORTED THAT THEY DO NOT INTEND TO PAY THEIR BILL, THAT THE COMPRESSION SYSTEM USED BY HER HUSBAND WAS DEFECTIVE AND DID NOT WORK, AND THAT HE DEVELOPED A BLOOD CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332664 ACTIVECARE +SFT HOMECARE COMPRESSIBLE LIMB SLEEVE JOW MEDICAL COMPRESSION SYSTEMS A502B-0002-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other