BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A MEDICAL DEVICE TO REMOVE FAT USING A PROCESS CALLED CRYOLIPOLYSIS

    MDR report key: 19744168 · Received July 12, 2024

    Report

    Report Number
    MW5157266
    Event Type
    Injury
    Date Received
    July 12, 2024
    Date of Event
    September 21, 2022
    Report Date
    July 10, 2024
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HAD THE COOL SCULPT PROCEDURE ON MY ABDOMEN. DIAGNOSED WITH PARADOXICAL ADIPOSE HYPERPLASIA (PAH) IN (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738555 A MEDICAL DEVICE TO REMOVE FAT USING A PROCESS CALLED CRYOLIPOLYSIS DERMAL COOLING PACK/VACUUM/MASSAGER OOK ZELTIQ AESTHETICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Other