BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICAL COMPRESSION HOSE

    MDR report key: 10217714 · Received June 30, 2020

    Report

    Report Number
    MW5095305
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    May 24, 2020
    Report Date
    June 26, 2020
    Manufacturer
    BSN-JOBST GMBH
    Product Code
    DWL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LOOKS LIKE MIGHT CAUSE DEEP VEIN THROMBOSIS. THE JOBST MEDICAL COMPRESSION HOSE ELASTIC FABRIC DOESN'T COMPARE WITH THE U.S. MADE BEFORE 2018. THE HOSE HAVE BEEN OUTSOURCED TO (B)(6). THE FABRIC IS WEAK AND LETS THE BLOOD STAGNATE AT THE ANKLES, CAUSING AWFUL AND VERY UNCOMFORTABLE SWELLING / LIGATION MAKING 2-3 WHITE RINGS AROUND ANKLES. THIS COULD CAUSE A BLOOD CLOT. THE HOSE HAD BEEN RECOMMENDED WAY BEFORE 2018 BY A DOCTOR, AS I WAS GETTING SPIDER VEINS AND TIRED LEGS. THIS OUTSOURCING IS BAD FOR OUR ECONOMY AND BAD FOR HEALTH. THESE HOSE ARE NOT INEXPENSIVE EITHER, ALMOST (B)(6). INCIDENT DATE: (B)(6) 2020. PURCHASE DATE: (B)(6) 2020. (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679627 MEDICAL COMPRESSION HOSE STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) DWL BSN-JOBST GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR