BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLCORE (6.3)

    MDR report key: 2894165 · Received December 27, 2012

    Report

    Report Number
    3007215625-2012-00030
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    July 20, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZELTIQ FOLLOWED UP WITH THE PHYSICIAN¿S OFFICE TO GATHER ADD¿L INFO BUT WAS UNABLE TO OBTAIN THE SERIAL NUMBER OF THE APPLICATOR USED. NO DEVICE MALFUNCTION WAS REPORTED TO ZELTIQ.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT A FEMALE PATIENT RECEIVED COOLSCULPTING TREATMENT WITH THE COOLCORE APPLICATOR (6.3) ON HER LEFT AND RIGHT BRA ROLL AREAS ON (B)(6) 2012. THE BRA ROLL AREAS ARE CONSIDERED OFF-LABEL SINCE THE ZELTIQ SYSTEM IS ONLY CLEARED IN THE USA FOR THE ABDOMEN AND FLANKS. THE PATIENT RETURNED TO THE OFFICE ON (B)(6) 2012 AND RECEIVED COOLSCULPTING TREATMENT TO THE UPPER ABDOMEN. ON (B)(6) 2012, THE OFFICE REPORTED THAT THE BRA ROLL AREAS HAVE SOFT ¿DIMPLES¿ THAT ARE NOT IN THE SHAPE OF THE APPLICATOR. ON (B)(6) 2012, THE AREA IS DESCRIBED AS LARGER THAN BEFORE THE TREATMENT DESPITE NO WEIGHT GAIN. ON (B)(6) 2012, ZELTIQ WAS INFORMED THAT THE PATIENT HAS DECIDED TO RECEIVE SMARTLIPO TO TREAT THE CONDITION, MAKING THIS A REPORTABLE EVENT. A FOLLOW-UP REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFO IS RECEIVED ABOUT THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention