BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 17419970 · Received July 28, 2023

    Report

    Report Number
    3007215625-2023-11152
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    February 15, 2019
    Report Date
    November 14, 2023
    Manufacturer
    ALLERGAN (PLEASANTON)
    Product Code
    OOK
    UDI-DI
    00816417020001
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE MALE CHEST ON (B)(6) 2019 USING THE COOLADVANTAGE COOLCURVE+ APPLICATOR. THE PATIENT DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) 1 MONTH AFTER TREATMENT. THE PATIENT WAS DIAGNOSED WITH PAH IN THE CHEST ON (B)(6) 2019. THE PAH WAS DESCRIBED AS FIRM AND THERE WAS VISIBLE ENLARGEMENT.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE MALE CHEST ON (B)(6) 2019 USING THE COOLADVANTAGE COOLCURVE+ APPLICATOR. THE PATIENT DEVELOPED PARADOXICAL HYPERPLASIA (PAH / PH) 1 MONTH AFTER TREATMENT. THE PATIENT WAS DIAGNOSED WITH PAH IN THE CHEST ON (B)(6) 2019. THE PAH WAS DESCRIBED AS FIRM AND THERE WAS VISIBLE ENLARGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334039 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN (PLEASANTON) NI 00816417020001

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention