BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLCORE (6.3)

    MDR report key: 3940220 · Received June 19, 2014

    Report

    Report Number
    3007215625-2014-00001
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 18, 2014
    Report Date
    June 6, 2014
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K133212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZELTIQ FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADD'L INFO. THE OFFICE REPORTED NO ERRORS OR DEVICE MALFUNCTIONS DURING THE TREATMENTS ON (B)(6) 2014. TREATMENT IN A PT WITH A HERNIA IN OR ADJACENT TO THE TREATMENT SITE IS CURRENTLY LISTED AS A WARNING IN THE COOLSCULPTING USER MANUAL. IN ADDITION, ZELTIQ HAS RECENTLY UPDATED THE USER MANUAL TO INCLUDE HERNIA AS A POSSIBLE RARE SIDE EFFECT. THIS UPDATE WAS MADE DURING DISCUSSIONS WITH FDA FOR THE 510 (K) SUBMISSION K133212. THIS USER MANUAL WILL BE DISTRIBUTED TO ALL CURRENT AND NEW CUSTOMERS. IT IS ZELTIQ'S POLICY TO BE CONSERVATIVE AND MAKE THIS REPORT. A F/U REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFO IS RECEIVED ABOUT THIS CASE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A MALE PT WAS TREATED TO THE UPPER ABDOMEN WITH TWO CYCLES OF THE COOLMAX APPLICATOR (8.0). THE TREATMENTS WERE UNEVENTFUL WITH NO ERROR CODES OR MALFUNCTION. ON (B)(6) 2014, THE PT RETURNED TO THE OFFICE FOR ADD'L TREATMENTS AND WAS TREATED ON THE LOWER AND UPPER ABDOMEN WITH THE COOLCORE APPLICATOR (6.3). AFTER THE TREATMENTS, A SMALL UMBILICAL HERNIA WAS NOTED. THE TREATING PHYSICIAN MANUALLY REDUCED THE HERNIA IN THE OFFICE. THE OFFICE REPORTED THAT THE TREATMENT AREA WAS ASSESSED FOR PRE-EXISTING HERNIAS PRIOR TO TREATMENT BUT NONE WAS NOTED. ON (B)(6) 2014, THE TREATING PHYSICIAN INFORMED ZELTIQ THAT THE HERNIA WAS LIKELY CAUSED BY THE COOLSCULPTING PROCEDURE. THE PHYSICIAN ALSO REPORTED THAT THE SMALL UMBILICAL HERNIA IS CURRENTLY NOT SERIOUS ENOUGH TO REQUIRE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359485 ZELTIQ COOLCORE (6.3) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COOLCORE APP 6.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention