BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLMAX (8.0)

    MDR report key: 3072356 · Received April 18, 2013

    Report

    Report Number
    3007215625-2013-00024
    Event Type
    Injury
    Date Received
    April 18, 2013
    Date of Event
    October 23, 2012
    Report Date
    March 19, 2013
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    PMA / PMN Number
    K120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZELTIQ FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADDITIONAL INFORMATION. PER THE PHYSICIAN'S OFFICE THE CONFIRMED PROCEDURE IN JUNE WAS CONDUCTED SUCCESSFULLY WITH NO MALFUNCTIONS. ZELTIQ REVIEWED THE SYSTEM LOGS FOR THAT TREATMENT DATE AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING THE TREATMENT. 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 INFORMATION IS RECEIVED ABOUT THIS CASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ZELTIQ WAS INFORMED THAT A MALE PT RECEIVED COOL-SCULPTING TREATMENT WITH THE COOLMAX APPLICATOR (8.0) ON HIS LOWER ABDOMEN ON (B)(6) 2012. ON (B)(6) 2013, THE PT CLAIMED TO HAVE TWO PREVIOUS TREATMENTS WHICH HAVE NOT BEEN CONFIRMED BY THE TREATING OFFICE. ON (B)(4) 2012, THE PT HAD RETURNED FOR FOLLOW-UP AND THE OFFICE REPORTED THAT THE TREATMENT AREA HAD INCREASED IN SIZE. THE PT RETURNED ON (B)(6) 2013 AND THE ENLARGEMENT HAD NOT DECREASED. ON (B)(6) 2013, THE OFFICE REPORTED THAT THE TREATED AREA APPEARED FIRMER THAN SURROUNDING TISSUE AND WOULD LIKELY REQUIRE SURGICAL INTERVENTION, MAKING THIS REPORTABLE. ON (B)(6) 2013, THE PT INFORMED ZELTIA THAT HE HAD LIPOSUCTION TO TREAT THE CONDITION ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167833 ZELTIQ COOLMAX (8.0) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS, INC. COOLMAX APP. 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention