BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLMAX (8.0)

    MDR report key: 2915053 · Received January 10, 2013

    Report

    Report Number
    3007215625-2013-00007
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    August 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZELTIQ FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADDITIONAL INFORMATION. PER THE PHYSICIAN'S OFFICE, THE PROCEDURE WAS CONDUCTED SUCCESSFULLY WITH NO MALFUNCTIONS. ZELTIQ REVIEWED THE SYSTEM LOGS AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING TREATMENT.

    Description of Event or Problem · 1

    A FEMALE PATIENT RECEIVED COOLSCULPTING TREATMENT ON (B)(6)/2012 WITH THE COOLMAX APPLICATOR (8.0) ON HER LOWER ABDOMEN, AND A COOLCORE APPLICATOR (6.3) ON HER MID ABDOMEN AND ON HER UPPER ABDOMEN. IN (B)(6) 2012, THE TREATMENT AREAS APPEARED ENLARGED. THE OFFICE DESCRIBED THE AREA AS FIRMER THAN SURROUNDING AREAS BUT STILL PLIABLE. ON (B)(6) 2012, A PLASTIC SURGEON RECOMMENDED AN ABDOMINOPLASTY TO TREAT THE CONDITION, MAKING THIS A REPORTABLE EVENT. THIS CASE HAS ALSO BEEN REPORTED FOR COOLCORE APP (6.3) IN MDR 3007215625-2013-00006. A FOLLOW-UP REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFORMATION IS RECEIVED ABOUT THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14898 ZELTIQ COOLMAX (8.0) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COLLMAX APP. 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention