BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAT FREEZER CRYOLIPOLYSIS SYSTEM

    MDR report key: 18658456 · Received February 6, 2024

    Report

    Report Number
    MW5151093
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 2, 2024
    Manufacturer
    FREEZE N FIT INC.
    Product Code
    OOK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED THE "ULTIMATE FAT FREEZER" PURCHASED FROM SHARPER IMAGE. LAST YEAR RECEIVED A SECOND DEGREE BURN ON RIGHT THIGH. SOUGHT CARE AT URGENT CLINIC. TREATED BY MD. ALSO TREATED BY DERMATOLOGIST AND GOT A TETANUS SHOT FROM MY NURSE PRACTITIONER. TOOK ALMOST A YEAR FOR BURN TO HEAL INTO FAINT SCAR. PURCHASED IT AGAIN AND USED IT (B)(6) 24. GOT ANOTHER BURN TO MY LEFT ABDOMEN. AM TREATING WITH SILVADINE DRESSING CHANGES. SEEING MY DERMATOLOGIST FOR THIS BURN TOO. BOTH INSTANCES I FOLLOWED MANUFACTURER DIRECTIONS AND PLACED A PROTECTANT SHEET BETWEEN DEVICE AND SKIN, SETTING TIMER ON DEVICE FOR 60 MINUTES. THIS PRODUCT SHARPER IMAGE IS SELLING IS VERY DANGEROUS! COMPLETED A REVIEW ONLINE WITH SHARPER IMAGE ABOUT THIS FAULTY DEVICE. I AM UPSET AND CONCERNED FOR THE PUBLIC. IT NEEDS TO BE PULLED OFF THE INTERNET/SHELVES/ETC. ORDER NUMBER FROM SHARPER IMAGE WEBSITE: 515604776. REFERENCE REPORT: MW5151092.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798188 FAT FREEZER CRYOLIPOLYSIS SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK FREEZE N FIT INC. BG-E-969 30133 40196

    Patients

    Seq Age Sex Outcome Treatment
    1