BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING® SYSTEM

    MDR report key: 17190757 · Received June 23, 2023

    Report

    Report Number
    3007215625-2023-00877
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    March 1, 2017
    Report Date
    June 23, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Removal / Correction Number
    Z-1346-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER OF THE DEVICE IS COOLSCUPLING: ZELTIQ AESTHETICS, INC., THE EVENT IS CONSERVATIVELY BEING REPORTED. ARTICLE CITATION: PUBMED ARTICLE (AMERICAN SOCIETY FOR DERMATOLOGIC SURGERY, INC.) TITLED, "PARADOXICAL HYPERPLASIA POST CRYOLIPOLYSIS AND MANAGEMENT" (PUBLISH DATE: 01-MARCH-2017). 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. ZELTIQ INITIATED A VOLUNTARY DISCONTINUATION AND RECALL OF PARALLEL PLATE APPLICATORS FOR THE COOLSCULPTING® SYSTEM DUE TO THE OBSERVANCE OF AN INCREASED RATE OF PARADOXICAL HYPERPLASIA (PH) ASSOCIATED WITH THESE APPLICATORS DURING A RECENT ANALYSIS OF DATA FROM THE 2019-2021 TIMEFRAME. THESE APPLICATORS ARE SOLD UNDER THE BRAND NAMES COOLCORE, COOLCURVE, COOLCURVE+, COOLMAX AND COOLFIT.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE ARTICLE, "PARADOXICAL HYPERPLASIA POST CRYOLIPOLYSIS AND MANAGEMENT", IT WAS REPORTED THAT A PATIENT [(B)(6)] WAS TREATED WITH COOLSCULPTING ON THE LOWER ABDOMEN WITH THE LEGACY COOLMAX APPLICATOR AND AND DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) 5 MONTHS AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447836 COOLSCULPTING® SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention