BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 12858725 · Received November 22, 2021

    Report

    Report Number
    3007215625-2021-02036
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    October 25, 2021
    Report Date
    February 11, 2025
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: A3, A4, B5 (TREATMENT DATE), D1, D4, D8, 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G3 (CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH #3007215625-2021-02036-01. AWARE DATE SHOULD HAVE BEEN LISTED AS 17/MAY/2024.).

    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.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT TO THE SUBMENTAL ON (B)(6) 2020 USING THE COOLMINI AND PRESENTED WITH PARADOXICAL HYPERPLASIA (PH).

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT TO THE SUBMENTAL ON (B)(6) 2020 USING THE COOLMINI AND PRESENTED WITH PARADOXICAL HYPERPLASIA (PH).

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLMINI TO THE CHIN, AND MAY HAVE DEVELOPED PARADOXICAL ADIPOSE HYPERPLASIA ON THE TREATED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755217 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention