BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING ELITE SYSTEM

    MDR report key: 17021252 · Received May 30, 2023

    Report

    Report Number
    3007215625-2023-00717
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    November 15, 2021
    Report Date
    November 20, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K183514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 (AREA OF CONCERN).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, A3, A4, B3, B5 (TREATMENT DATES, DIAGNOSED AREAS, APPLICATOR, DATE OF DIAGNOSIS), D1

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 (TREATMENT DATE). H11 - CORRECTED DATA: G3 (USED TO CORRECT AWARE DATE), B5 (AREA OF CONCERN).

    Additional Manufacturer Narrative · 0

    THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT TREATED THE UPPER ABDOMEN, FLANKS, AND UPPER ARMS ON (B)(6) /2021, AND (B)(6) 2023 WITH COOLSCULPTING COOLADVANTAGE, COOLADVANTAGE+, AND COOLSMOOTHPRO APPLICATORS AND COOLCORE, COOLCURVE, COOLCURVE+, AND COOLFIT AND COOLSCULPTING ELITE CURVE 150, CURVE 240, AND FLAT 165 HAS DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). DIAGNOSED ON 11/MAY/2023 WITH PARADOXICAL ADIPOSE HYPERPLASIA (PAH) BY MEDICAL PROFESSIONAL.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED THE UPPER ARM, UPPER, MID, LOW ABDOMEN, INNER THIGH, AND FLANKS ON (B)(6) 2021, (B)(6) 2021, WITH COOLSCULPTING COOLADVANTAGE COOLCORE, COOLADVANTAGE COOLFIT, COOLADVANTAGE COOLCURVE+, COOLADVANTAGE COOLSMOOTH/COOLSMOOTHPRO, AND COOLSCULPTING ELITE CURVE 150, CURVE 240, FLAT 165 HAS DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). DIAGNOSED ON (B)(6) 2023 WITH PARADOXICAL ADIPOSE HYPERPLASIA (PAH) BY MEDICAL PROFESSIONAL.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED THE UPPER ABDOMEN AND FLANKS ON (B)(6) 2021, AND (B)(6) 2023 WITH COOLSCULPTING COOLADVANTAGE, COOLADVANTAGE+, AND COOLSMOOTHPRO APPLICATORS AND COOLCORE, COOLCURVE, COOLCURVE+, AND COOLFIT AND COOLSCULPTING ELITE CURVE 150, CURVE 240, AND FLAT 165 HAS DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). DIAGNOSED ON (B)(6) 2023 WITH PARADOXICAL ADIPOSE HYPERPLASIA (PAH) BY MEDICAL PROFESSIONAL.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885885 COOLSCULPTING ELITE SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention