BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLMAX (8.0)

    MDR report key: 3023854 · Received March 26, 2013

    Report

    Report Number
    3007215625-2013-00018
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZELTIQ FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADD'L INFO. PER THE PHYSICIAN'S OFFICE, THE PROCEDURE WAS CONDUCTED SUCCESSFULLY WITH NO MALFUNCTIONS. ZELTIQ REVIEWED THE SYSTEM LOGS FOR THE TREATMENT DATES AND CONFIRMED THAT NO SYSTEM MALFUNCTIONS OCCURRED DURING THE TREATMENTS.

    Description of Event or Problem · 1

    A FEMALE PT REC'D COOLSCULPTING TREATMENT WITH THE COOLMAX APPLICATOR (8.0) TO THE LOWER ABDOMEN ON (B)(6) 2012. THE PT RETURNED TO THE OFFICE ON (B)(6) 2013 FOR FOLLOW-UP. THE OFFICE REPORTED THAT THE PT'S FAT SEEMED TO HAVE BECOME FIRM AND APPEARS TO BE PROTRUDING. ON (B)(6) 2013, ZELTIQ REC'D PHOTOS THAT INDICATED AN ENLARGEMENT. INTERVENTION WILL LIKELY BE NEEDED TO TREAT THE CONDITION, MAKING THIS REPORTABLE. IT IS ZELTIQ'S POLICY TO BE CONSERVATIVE AND MAKE THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE TO THE AGENCY IF AND WHEN INFO IS REC'D ABOUT THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124563 ZELTIQ COOLMAX (8.0) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COLMAX APP. 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention