BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUELMEFOOT COPPER COMPRESSION SOCK

    MDR report key: 12136148 · Received July 8, 2021

    Report

    Report Number
    MW5102347
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    May 1, 2020
    Report Date
    July 1, 2021
    Manufacturer
    UNK
    Product Code
    DWL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS WEARING A COMPRESSION SOCK CONTAINING COPPER. HE IS DIABETIC AND HAS NEUROPATHY WHICH STARTS JUST BELOW HIS KNEE, SO HE DOES NOT HAVE GOOD SENSATION OF THE SKIN JUST BELOW THE KNEE ALL THE WAY TO HIS TOES. HE WAS SITTING IN THE SUN FOR SEVERAL HOURS. LATER ON HE NOTICED BLISTERING OF THE RIGHT LEG WHEN HE REMOVED THE SOCK. HE ULTIMATELY HAD THIRD DEGREE BURNS AND REQUIRED MEDICAL TREATMENT WITH MANY VISITS TO A WOUND CLINIC. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035950 FUELMEFOOT COPPER COMPRESSION SOCK STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) DWL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R