BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPRO COLD THERAPY MACHINE FOR (ANKLE, CALF, THIGH) WITH REMOTE AND 5 COMPRESS

    MDR report key: 15715524 · Received November 1, 2022

    Report

    Report Number
    MW5113019
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    February 22, 2022
    Report Date
    October 31, 2022
    Manufacturer
    LIFEPRO FITNESS LLC
    Product Code
    IRP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AMAZON SELLER LIFEPRO OUTLETS IS GOING SELLING MEDICAL PRODUCT AIR COMPRESSION COLD THERAPY MACHINE WITHOUT 510K, IT IS ILLEGAL. LIFEPRO AIR COMPRESSION COLD THERAPY MACHINE EXPLODED BEFORE AND MADE MY LEG HURT. LIFEPRO SHOULD STOP SELLING ILLEGAL MEDICAL PRODUCT IN CASE DAMAGE MORE AMERICANS' LIFE. PLEASE STOP LIFEPRO OUTLET SELLS ANY ILLEGAL MEDICAL PRODUCTS. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM FDA FOR REPORT MW5113019 TO UPDATE PROCODE TO IRP AND MANUFACTURER TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909006 LIFEPRO COLD THERAPY MACHINE FOR (ANKLE, CALF, THIGH) WITH REMOTE AND 5 COMPRESS MASSAGER, POWERED INFLATABLE TUBE IRP LIFEPRO FITNESS LLC
    2949024 LIFEPRO COLD THERAPY MACHINE FOR (ANKLE, CALF, THIGH) WITH REMOTE AND 5 COMPRESS MASSAGER, POWERED INFLATABLE TUBE IRP LIFEPRO FITNESS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Life Threatening