BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALP

    MDR report key: 12445683 · Received September 9, 2021

    Report

    Report Number
    12445683
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 9, 2021
    Report Date
    September 7, 2021
    Manufacturer
    CURRIE MEDICAL SPECIALTIES INC.
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LEFT LEG WRAP HAS A HOLE AND IT WOULD NOT INFLATE. MANUFACTURER RESPONSE FOR ALTERNATING LEG PRESSURE DEVICE, ALTERNATING LEG PRESSURE 1A (PER SITE REPORTER). CURRIE MEDICAL NOTIFIED OF EQUIPMENT FAILURE. CUSTOMER SERVICE MANAGER ARRANGED FOR REPLACEMENT GARMENT BE SENT TO DIRECTOR MEDICAL SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344934 ALP SLEEVE, LIMB, COMPRESSIBLE JOW CURRIE MEDICAL SPECIALTIES INC. ALP® 1A CALF-R F2105-134

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA