BEUDAMED
    FDA Adverse Event Death Summary report: N

    GARMENT,DVT,INT,GEN2,CALF,MEDIUM

    MDR report key: 23233618 · Received October 7, 2025

    Report

    Report Number
    1417592-2025-00527
    Event Type
    Death
    Date Received
    October 7, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 7, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, "THEY HOOKED THE PATIENT UP TO SCD MACHINE ON (B)(6). THE PATIENT DEVELOPED A DVT AND DIED ON (B)(6) AS A RESULT." PER THE FACILITY, HE GOT HIS DVT IN TICU AND WAS DOWNGRADED ON A HEPARIN GTT ON (B)(6). HE WAS ONLY ON THE HEPARIN GTT BECAUSE OF THE DVT AND ITS LOCATION. HE CODED 3 TIMES ON (B)(6) ON THE FLOOR AND WAS BROUGHT BACK TO TICU, WHERE HE PASSED AWAY ON (B)(6). BY THIS TIME, HE WAS MAXED OUT ON MULTIPLE PRESSORS." IT WAS FOUND THAT THE SLEEVES WERE NOT INFLATING. NO ADDITIONAL INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY, "THEY HOOKED THE PATIENT UP TO SCD MACHINE ON (B)(6). THE PATIENT DEVELOPED A DVT AND DIED ON (B)(6) AS A RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488390 GARMENT,DVT,INT,GEN2,CALF,MEDIUM JOW MEDLINE INDUSTRIES, LP 65124100010

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death| O