BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 17596769 · Received August 22, 2023

    Report

    Report Number
    3007215625-2023-13387
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    December 15, 2018
    Report Date
    November 27, 2023
    Manufacturer
    ALLERGAN (PLEASANTON)
    Product Code
    OOK
    UDI-DI
    00816417020001
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    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 FEMALE PATIENT TREATED WITH COOLSCULPTING TO THE BILATERAL UPPER, MID, AND LOWER ABDOMEN ON (B)(6) 2018 USING THE COOLADVANTAGE PLUS, COOLCURVE PLUS APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) 5 MONTHS AFTER TREATMENT. ON (B)(6) 2019 THE PATIENT WAS DIAGNOSED WITH PAH TO THE UPPER, MID, AND LOWER ABDOMEN. PAH WAS CONFIRMED IN THE UPPER AND MIDDLE ABDOMEN. PAH WAS DESCRIBED AS VERY FIRM, NOTICEABLY LARGER THAN PREVIOUS PALPATION, AND SLIGHTLY TENDER.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A FEMALE PATIENT TREATED WITH COOLSCULPTING TO THE BILATERAL UPPER, MID, AND LOWER ABDOMEN ON (B)(6) 2018 USING THE COOLADVANTAGE PLUS, COOLCURVE PLUS APPLICATOR WHO DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) 5 MONTHS AFTER TREATMENT. ON (B)(6) 2019 THE PATIENT WAS DIAGNOSED WITH PAH TO THE UPPER, MID, AND LOWER ABDOMEN. PAH WAS CONFIRMED IN THE UPPER AND MIDDLE ABDOMEN. PAH WAS DESCRIBED AS VERY FIRM, NOTICEABLY LARGER THAN PREVIOUS PALPATION, AND SLIGHTLY TENDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45889 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN (PLEASANTON) NI 00816417020001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention