BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING HOLLYWOOD BODY LASER

    MDR report key: 16447134 · Received February 24, 2023

    Report

    Report Number
    MW5115251
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    September 15, 2017
    Report Date
    February 22, 2023
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    COOLSCULPTING ON LOWER ABDOMEN RESULTED IN PAH. TREATED AREA BECAME ROCK HARD AFTER 6 WEEKS. AFTER NUMEROUS COMPLAINTS, (B)(6) IN (B)(6) AGREED TO FILE A CLAIM WITH ZELTIQ. REQUIRED SURGICAL REMOVAL WHICH MEANT 6 MONTHS RECUPERATION, LOST WAGES. HEALTHY EXERCISER NON SMOKER NON DRUG USER NON ALCOHOLIC DRINKER NO CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381592 COOLSCULPTING HOLLYWOOD BODY LASER DERMAL COOLING PACK/VACUUM/MASSAGER OOK ZELTIQ AESTHETICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other| H| R