BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 13972504 · Received April 1, 2022

    Report

    Report Number
    3007215625-2022-00469
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    January 1, 2022
    Report Date
    May 16, 2025
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K183514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PARADOXICAL ADIPOSE HYPERPLASIA 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF AND WHEN ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: AWARE DATE. SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2022-00919-00.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: A3, A4, A6, B3, B5 (TREATMENT DATE, APPLICATOR, AREA OF CONCERN), D1, D4, D8, E3, G1, H6, H11. PARADOXICAL ADIPOSE HYPERPLASIA (PH) IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. ACCORDING TO THE COOLSCULPTING USER MANUAL, UNDER RARE ADVERSE EVENTS, PH 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. PH 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

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENTS IN (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2022 TO UPPER AND LOWER ABDOMEN AND FLANKS WITH THE COOLSCULPTING ELITE CONTROL UNIT AND MAY HAVE DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA. THE PATIENT FIRST NOTICED SYMPTOMS IN (B)(6) 2021 WHEN IT WAS OBSERVED THE BODY WAS GETTING BIGGER AND IRREGULAR.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH, THIS REPORT HAS BEEN IDENTIFIED AS A DUPLICATE OF PREVIOUSLY SUBMITTED MEDWATCH REPORT OF 3007215625-2022-00919-00.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT TO THE FLANKS AND LOW ABDOMEN ON (B)(6) 2021 AND (B)(6) 2021 USING THE COOLADVANTAGE APPLICATOR WITH COOLCORE AND COOLCURVE+ CONTOURS AND PRESENTED WITH PARADOXICAL HYPERPLASIA (PH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2794305 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Required Intervention