BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING

    MDR report key: 12662563 · Received October 18, 2021

    Report

    Report Number
    MW5104743
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    June 28, 2018
    Report Date
    October 15, 2021
    Manufacturer
    ZELTIQ AESTHETICS INC
    Product Code
    OOK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2018, I HAD COOLSCULPTING AT (B)(6) SPA IN (B)(6) TO TREAT FAT UNDER MY CHIN. AFTERWARDS, THE FAT INCREASED AND BECAME FIBROUS AND I AM BEING DIAGNOSED WITH PARADOXICAL ADIPOSE HYPERPLASIA (PAH), WHICH I HAVE LEARNED IS AN ADVERSE EFFECT OF THE COOLSCULPTING AND MUCH MORE COMMON THAT PREVIOUSLY THOUGHT OR DISCLOSED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550179 COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ZELTIQ AESTHETICS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other