BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING® SYSTEM

    MDR report key: 16924136 · Received May 12, 2023

    Report

    Report Number
    3007215625-2023-00639
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 12, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING TO THE UPPER ABDOMEN AND LOWER ABDOMEN ON (B)(6) 2022 USING COOLADVANTAGE PLUS COOLCORE AND MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH) TWO TO THREE MONTHS AFTER TREATMENT. REGISTERED NURSE DIAGNOSIS WITH PH ON (B)(6) 2023 WITHIN CEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309226 COOLSCULPTING® SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention