BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 17436743 · Received August 1, 2023

    Report

    Report Number
    3007215625-2023-11430
    Event Type
    Injury
    Date Received
    August 1, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ALLERGAN (PLEASANTON)
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A HISTORICAL RECORD AND REFLECTS REPORTS THAT WERE RECEIVED BY THE COMPANY PRIOR TO APRIL 2021. ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE HYPERPLASIA (PH/PAH) IS CHARACTERIZED BY A VISIBLY ENLARGED TISSUE VOLUME WITHIN THE TREATMENT AREA, WHICH MAY DEVELOP TWO TO FIVE MONTHS AFTER TREATMENT. SURGICAL INTERVENTION MAY BE REQUIRED. PAH IS NOT RELATED TO ANY COOLSCULPTING DEVICE FAILURE MODE BUT IT IS INCLUDED IN THE RISK MANAGEMENT FILES OF THE DEVICE BECAUSE IT IS A RISK THAT IS INHERENT TO THE USE CRYOLIPOLYSIS FOR LOCALIZED FAT REDUCTION. ABBVIE IS UNABLE TO CONFIRM WITH THE HEALTHCARE PROFESSIONAL; THEREFORE, ADDITIONAL EVENT, PRODUCT, OR PATIENT DETAILS ARE NOT ATTAINABLE.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A SOCIAL MEDIA REPORT STATING: "I DID COOL SCULPTING AND ALL IT DID WAS PUMPED MY WHOLE STOMACH UP AND RUINED IT I RECOMMEND NO ONE DOES THIS!"

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A SOCIAL MEDIA REPORT STATING: "I DID COOL SCULPTING AND ALL IT DID WAS PUMPED MY WHOLE STOMACH UP AND RUINED IT I RECOMMEND NO ONE DOES THIS!"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343156 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN (PLEASANTON) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention