BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLMAX APP (8.0)

    MDR report key: 2860516 · Received December 5, 2012

    Report

    Report Number
    3007215625-2012-00023
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    August 1, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K080521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE POSSIBILITY OF THIS OCCURRENCE BEING RELATED TO THE COOLSCULPTING PROCEDURE CANNOT BE EXCLUDED, EVEN THOUGH IT IS POSSIBLE THAT THE PATIENT HAD A PREVIOUSLY UNDIAGNOSED UMBILICAL HERNIA, WHICH IS A VERY COMMON OCCURRENCE IN WOMEN. IT IS ZELTIQ'S POLICY TO BE CONSERVATIVE AND TO MAKE THIS REPORT.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT A FEMALE PATIENT RECEIVED COOLSCULPTING TREATMENT OVER THE UMBILICUS APPROXIMATELY 2 YEARS AGO WITH THE 6 SERIES APPLICATOR. SHE RECEIVED A SECOND COOLSCULPTING TREATMENT SOMETIME IN (B)(6) 2012 WITH THE COOLMAX APP (8.0). APPROXIMATELY 1-2 WEEKS AFTER TREATMENT, THE PATIENT DEVELOPED A MOVEABLE NODULE THAT WAS DIAGNOSED AS AN UMBILICAL HERNIA BY THE TREATING PHYSICIAN DURING THE FIRST WEEK OF (B)(6) 2012. ON (B)(6) 2012, ZELTIQ WAS NOTIFIED THAT THE PHYSICIAN HAS RECOMMENDED SURGICAL REPAIR MAKING THIS A REPORTABLE EVENT. 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
    1 ZELTIQ COOLMAX APP (8.0) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COOLMAX APP 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention