BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 14104970 · Received April 12, 2022

    Report

    Report Number
    MW5108950
    Event Type
    Injury
    Date Received
    April 12, 2022
    Date of Event
    June 6, 2019
    Report Date
    April 10, 2022
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A ZELTIQ COOLSCULPTING TREATMENT FROM THE BODYCOUTURE GROUP LLP D/B/A BELOW BODY BAR ON MY ARMS AND MY BACK. THE TREATMENTS CAUSED PAH, FAT DEPOSITS ON THE TREATMENT AREA. MY ARMS AND BACK ARE NOW DISFIGURED. CRYOLIPOLYSIS IS USED TO "FREEZE" FAT--A LIE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786906 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ZELTIQ AESTHETICS, INC. K151179

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female VITAMIN D