BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING

    MDR report key: 12829155 · Received November 16, 2021

    Report

    Report Number
    MW5105381
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    November 9, 2021
    Report Date
    November 13, 2021
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PARADOXICAL HYPERPLASIA OF THE ABDOMEN S/P COOLSCULPTING PROCEDURE. (COOLSCULPTING MACHINE BY ZELTIQ) PROCEDURE PERFORMED IN (B)(6) 2020. DEVELOPED ENLARGED TISSUE DEFORMITIES IN THE TREATED AREA OF THE ABDOMINAL WALL AND UNDER HER CHIN FOR WHICH SHE STARTED TO NOTICE IN (B)(6) 2021. SIGNIFICANTLY ALTERING HER APPEARANCE. DIAGNOSED WITH PARADOXICAL HYPERPLASIA ON (B)(6) 2021. SHE WAS TREATED WITH THE COOLMINI APPLICATOR WITH 4 CYCLES UNDER THE CHIN. COOLADVANTAGE APPLICATOR WITH 2 CYCLES UPPER ABDOMEN AND COOLADVANTAGE PLUS FOR 2 CYCLES LOWER ABDOMEN. ALL TREATMENTS WERE DONE AT THE MANUFACTURERS SETTINGS, FOLLOWING STANDARD PROTOCOLS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716340 COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ZELTIQ AESTHETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Disability