BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLMAX (8.0)

    MDR report key: 2925149 · Received January 17, 2013

    Report

    Report Number
    3007215625-2013-00008
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    May 1, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    PMA / PMN Number
    K120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING TREATMENT.

    Description of Event or Problem · 1

    A MALE PT RECEIVED COLLSCULPTING TREATMENT ON (B)(6) 2011, WITH THE COOLMAX (8.0) APP ON HIS LOWER ABDOMEN. THE PT RETURNED TO THE OFFICE ON (B)(6) 2012 AND REPORTED THAT HE NOTICED THE TREATMENT AREA HAD BEGUN TO INCREASE APPROX SIX MONTHS POST-PROCEDURE. ON (B)(6) 2012, ZELTIQ WAS INFORMED THAT THE TREATING PHYSICIAN HAD RECOMMENDED INTERVENTION OPTIONS TO TREAT THE CONDITION, MAKING THIS A REPORTABLE EVENT. A F/U 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
    25776 ZELTIQ COOLMAX (8.0) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS, INC. COOLMAX APP. 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention