BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL SCULPT

    MDR report key: 3151801 · Received June 3, 2013

    Report

    Report Number
    MW5030450
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    January 20, 2012
    Report Date
    June 3, 2013
    Manufacturer
    ZELTIQ
    Product Code
    OOK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WENT IN TO HAVE COOL SCULPTING ZELTIQ DONE ON MY ABDOMEN. THE RESULT IS A PERMANENT INDENTATION ON TWO SIDES OF MY STOMACH. THEY HAVE TRIED TO CORRECT THE PROBLEM ON TWO SEPARATE OCCASIONS AND THE RESULT IS STILL THE SAME. DOSE OR AMOUNT: 1 HR SESSION; 1 TIME; EPIDURAL. REASON FOR USE: REMOVE SMALL POCKET OF FAT AT TOP OF ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242942 COOL SCULPT COOL SCULPT MACHINE OOK ZELTIQ

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability