BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLCORE (6.3)

    MDR report key: 3023852 · Received March 26, 2013

    Report

    Report Number
    3007215625-2013-00020
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    December 25, 2012
    Report Date
    February 27, 2013
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 DATE AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING TREATMENT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    A FEMALE PT REC'D COOLSCULPTING TREATMENT WITH THE COOLCORE APPLICATOR (6.3) ON HER UPPER AND LOWER ABDOMEN ON (B)(6) 2012. THE PT RETURNED TO THE OFFICE ON (B)(6) 2013 AT WHICH TIME THE OFFICE NOTED THAT SHE HAD FIRMNESS AND TENDERNESS ON HER UPPER ABDOMEN ONLY. THE OFFICE ALSO NOTED THAT THE PT NOTICED THE ONSET OF SYMPTOMS ON (B)(6) 2012. ZELTIQ WAS THEN INFORMED ON (B)(6) 2013 THAT THE PT NOTICED AN ENLARGEMENT AFTER EACH OF THE THREE TREATMENTS. ZELTIQ REC'D PHOTOS OF THE THREE TREATMENTS. ZELTIQ REC'D PHOTOS ON (B)(6) 2013 THAT CONFIRMED THE ENLARGEMENT ON THE UPPER ABDOMEN. THE PT HAS ALSO REPORTEDLY GAINED EIGHT POUNDS FROM (B)(6). IT IS LIKELY THAT INTERVENTION WILL BE REQUIRED 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 NEW INFO IS REC'D ABOUT THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123137 ZELTIQ COOLCORE (6.3) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COOLCORE APP. 6.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention