BEUDAMED
    FDA Adverse Event Summary report: N

    COMPRESSIONZ COMPRESSION SOCKS

    MDR report key: 6791600 · Received August 11, 2017

    Report

    Report Number
    MW5071552
    Date Received
    August 11, 2017
    Date of Event
    July 31, 2017
    Manufacturer
    COMPRESSIONZ
    Product Code
    FQL
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED SEVERAL PAIRS OF COMPRESSION SOCKS THROUGH (B)(6) MADE BY (B)(6). THE SOCKS ARE GREAT AND I REALLY LIKE THEM, SO I HAVE ORDERED 15 PAIRS. I LOVED THESE SOCKS UNTIL TODAY THAT IS! I WALKED THROUGH A WELDING SHOP AND A SPARK STRUCK MY RIGHT SOCK AND IT BURST INTO FLAMES! THE "FUZZ" OF THE MATERIAL IGNITED VIOLENTLY OVER THE ENTIRE SOCK. THE FLAMES DIED OUT QUICKLY ONLY SCORCHING MY LEG HAIR AND CAUSING A SLIGHT SURFACE BURN. THESE SOCKS HAVE BEEN WASHED SEVERAL TIMES AND WERE CLEAN. NOT ONLY WOULD I SAY THESE SOCKS ARE NOT FLAME RETARDANT, I WOULD SAY THEY ARE FLAMMABLE! I REALIZE THE FIRE ONLY INVOLVED THE FUZZY SURFACE, AND ONCE IT BURNED OFF, THE FLAMES QUICKLY DISSIPATED. HOWEVER THIS COULD EASILY SPREAD TO OTHER COMBUSTIBLE MATERIALS. PLEASE EXAMINE THIS PRODUCT TO ENSURE IT MEETS THE REQUIRED SAFETY STANDARDS. INCIDENT LOCATION: (B)(6). PRODUCT CATEGORY: CLOTHING AND ACCESSORIES. RETAILER: (B)(6). PURCHASE DATE: (B)(6) 2017. I STILL HAVE THE PRODUCT IN MY POSSESSION: YES. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570567 COMPRESSIONZ COMPRESSION SOCKS COMPRESSIONZ COMPRESSION SOCKS FQL COMPRESSIONZ

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR