BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLCORE (6.3)

    MDR report key: 3060085 · Received April 11, 2013

    Report

    Report Number
    3007215625-2013-00023
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    September 1, 2012
    Report Date
    March 13, 2013
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE MULTIPLE ATTEMPTS, ZELTIQ WAS UNABLE TO OBTAIN SYS LOGS. THE OFFICE REPORTED THAT THE TREATMENTS WERE UNEVENTFUL. 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 NEW INFO IS REC'D ABOUT THIS CASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ZELTIQ WAS INFORMED OF A FEMALE PT WHO REC'D COOLSCULPTING TREATMENT ON (B)(6) 2012 WITH THE COOLCORE APPLICATOR (6.3) ON HER LOWER ABDOMEN. THE TREATMENT WAS SUCCESSFUL WITH NO DEVICE MALFUNCTION. THE PT REPORTED GOOD REDUCTION. ON (B)(6) 2012, THE PT RECEIVED ANOTHER TREATMENT ABOVE THE FIRST TREATED AREA ON THE LOWER ABDOMEN. APPROXIMATELY FIVE WEEKS AFTER THIS TREATMENT, THE PT NOTICED AN ENLARGEMENT IN THE TREATED AREA. ON (B)(6) 2012, THE PT REC'D A THIRD TREATMENT TO ADDRESS THE ENLARGEMENT. THE PT SUBSEQUENTLY HAD TWO MORE TREATMENTS ON (B)(6) 2012 TO ADDRESS THE ISSUE. THE PT REPORTED THAT SHE HAS TWO ENLARGEMENTS ON EACH SIDE OF THE ABDOMEN, WITH THE LEFT SIDE MORE PRONOUNCED THAN THE RIGHT SIDE. SHE DESCRIBED THE ENLARGEMENTS AS BEING NON-TENDER. ON (B)(6) 2013, ZELTIQ WAS INFORMED THAT THE PT HAD UNDERGONE SURGERY TO CORRECT THE CONDITION, MAKING THIS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155338 ZELTIQ COOLCORE (6.3) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COOLCORE APP. 6.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention