BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 15540790 · Received October 4, 2022

    Report

    Report Number
    3007215625-2022-01521
    Event Type
    Injury
    Date Received
    October 4, 2022
    Date of Event
    April 28, 2021
    Report Date
    December 6, 2023
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    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 OBSERVED MORE FREQUENTLY WITH THE PARALLEL PLATE APPLICATORS. PAH IS INCLUDED IN THE RISK MANAGEMENT FILES OF THE DEVICE AS AN INHERENT RISK TO THE USE OF CRYOLIPOLYSIS FOR LOCALIZED FAT REDUCTION. 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.

    Additional Manufacturer Narrative · 0

    H11 - CORRECTED DATA: D1.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED WITH COOLSCULPTING MAY HAVE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). DUE TO INSUFFICIENT INFORMATION, POSSIBLE PAH LOCATION, DEVICE INFO AND TREATMENT DATE IS NOT DOCUMENTED.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED ABDOMEN WITH COOLSCULPTING COOLADVANTAGE COOLCARE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). DIAGNOSED WITH PAH ON (B)(6) 2022 BY FAMILY NURSE PRACTITIONER.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED ABDOMEN WITH COOLSCULPTING COOLADVANTAGE COOLCARE DEVELOPED PARADOXICAL HYPERPLASIA (PAH/PH). DIAGNOSED WITH PAH ON (B)(6) 2022 BY FAMILY NURSE PRACTITIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149968 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention