BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 17453543 · Received August 3, 2023

    Report

    Report Number
    3007215625-2023-11655
    Event Type
    Injury
    Date Received
    August 3, 2023
    Date of Event
    January 15, 2018
    Report Date
    November 15, 2023
    Manufacturer
    ALLERGAN (PLEASANTON)
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA D1 - BRAND NAME.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A MALE PATIENT TREATED WITH COOLSCULPTING TO LOWER ABDOMEN WITH 1 CYCLE OF COOLMAX AND POSTERIOR FLANKS WITH 2 CYCLES OF COOLADVANTAGE COOLCURVE PLUS ON (B)(6) 2016 WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) AFTER TREATMENT. ON (B)(6) 2018, CEF REPORTED PATIENT RECENTLY CALLING IN OFFICE COMPLAINING HE WAS NOT HAPPY ABOUT THE RESULTS AND FELT IT GOT WORSE. DIAGNOSED ON (B)(6)2018 OF THE LOWER AND POSTERIOR FLANKS. PAH WAS DESCRIBED AS ENLARGED AND FIRM.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A MALE PATIENT TREATED WITH COOLSCULPTING TO LOWER ABDOMEN WITH 1 CYCLE OF COOLMAX AND POSTERIOR FLANKS WITH 2 CYCLES OF COOLADVANTAGE COOLCURVE PLUS ON (B)(6) 2016 WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) AFTER TREATMENT. ON (B)(6) 2018, CEF REPORTED PATIENT RECENTLY CALLING IN OFFICE COMPLAINING HE WAS NOT HAPPY ABOUT THE RESULTS AND FELT IT GOT WORSE. DIAGNOSED ON (B)(6)2018 OF THE LOWER AND POSTERIOR FLANKS. PAH WAS DESCRIBED AS ENLARGED AND FIRM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657544 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN (PLEASANTON) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention V0802016235002, V1602016148004