BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING SYSTEM

    MDR report key: 13255759 · Received January 13, 2022

    Report

    Report Number
    3007215625-2022-00106
    Event Type
    Injury
    Date Received
    January 13, 2022
    Date of Event
    December 22, 2021
    Report Date
    May 21, 2025
    Manufacturer
    ALLERGAN PLEASANTON
    Product Code
    OOK
    UDI-DI
    00816417020001
    PMA / PMN Number
    K160259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    CORRECTION TO G.3. AWARE DATE OF SUPPLEMENTAL MEDWATCH #3007215625-2022-00106-01. AWARE DATE SHOULD HAVE BEEN LISTED AS 21/SEP/2022.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT AND PRESENTED WITH POSSIBLE PARADOXICAL ADIPOSE HYPERPLASIA.

    Description of Event or Problem · 0

    ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT WHO RECEIVED COOLSCULPTING TREATMENT AND PRESENTED WITH POSSIBLE PARADOXICAL ADIPOSE HYPERPLASIA.

    Description of Event or Problem · 0

    PREVIOUS EMDR SUBMISSION NOTED PARADOXICAL HYPERPLASIA. UPON FURTHER REVIEW BY ABBVIE MEDICAL SAFETY PHYSICIANS, IT HAS BEEN DETERMINED THAT THE EVENT IS NOT CONSISTENT WITH PH. HENCE, THE RECORD IS NO LONGER REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332455 COOLSCULPTING SYSTEM DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN PLEASANTON NI 00816417020001

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention