BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLSCULPTING

    MDR report key: 6106016 · Received November 14, 2016

    Report

    Report Number
    MW5066069
    Event Type
    Injury
    Date Received
    November 14, 2016
    Date of Event
    June 1, 2016
    Report Date
    November 14, 2016
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD COOLSCULPTING OF LOWER ABDOMEN ON (B)(6) 2016 AND FLANKS ON (B)(6) 2016. NO COMPLICATIONS AT TIME OF PROCEDURES. ON (B)(6) 2016, PT REPORTED THAT SINCE (B)(6) 2016, HE EXPERIENCED ENLARGEMENT OF FAT IN THE LOWER ABDOMEN AREA INCLUDING FLANKS AND STRETCH MARKS OF THE RIGHT LOWER ABDOMEN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749994 COOLSCULPTING COOLSCULPTING OOK ZELTIQ AESTHETICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR