BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPRO COLD COMPRESSION THERAPY MACHINE

    MDR report key: 13619390 · Received February 25, 2022

    Report

    Report Number
    MW5107762
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    February 16, 2022
    Report Date
    February 24, 2022
    Manufacturer
    CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO.,LTD
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I ORDERED LIFEPRO COLD AIR COMPRESSION THERAPY MACHINE ON (B)(6) 2022 ON (B)(6) AND THEN USED IT. I USED THE AIR COMPRESSION THERAPY MACHINE ON (B)(6) AND AIR PUMP COMPRESSION REACHED 100MMHG, WHICH IS TOO MUCH PRESSURE, MAKES LEG WRAP EXPLODE, MY LEG WAS BLEEDING. I FIND LIFEPRO COLD AIR COMPRESSION THERAPY MACHINE IS MEDICAL CLASS II WITHOUT A 510K; IT IS ILLEGAL TO SELL AIR COMPRESSION THERAPY MACHINE WITHOUT A 510K. THIS MACHINE DAMAGED MY BODY, MY LIFE. TO PROTECT MORE AMERICAN LIVES, PLEASE INFORM LIFEPRO TO STOP SELLING AIR COMPRESSION THERAPY MACHINE ON (B)(6) AND PUNISH THIS COMPANY. LIFEPRO (B)(6) LINK IS FOLLOWING, ILLEGAL (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298101 LIFEPRO COLD COMPRESSION THERAPY MACHINE SLEEVE, LIMB, COMPRESSIBLE JOW CHENGDU CRYO-PUSH MEDICAL TECHNOLOGY CO.,LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Life Threatening