BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING

    MDR report key: 18640436 · Received February 2, 2024

    Report

    Report Number
    MW5151014
    Event Type
    Injury
    Date Received
    February 2, 2024
    Report Date
    February 2, 2024
    Manufacturer
    ALLERGAN / ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER WENT TO A MEDICAL SPA TO HAVE COOLSCULPTING DONE. SHE WAS TOLD SHE IS A GOOD CANDIDATE SO SHE PROCEEDED TO HAVE PROCEDURE DONE. TIME PASSED AFTER THE PROCEDURE AND SHE NOTICED A LARGE BLACK HOLE ON HER SKIN. SHE DEVELOPED PSORIASIS WHICH CAUSED ITCHING. SHE STATES "THERE IS NO REGULATION FROM THE FDA" AND PEOPLE NEED TO BE AWARE OF THE POTENTIAL HARM IT CAN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091143 COOLSCULPTING DERMAL COOLING PACK/VACUUM/MASSAGER OOK ALLERGAN / ZELTIQ AESTHETICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female