BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLMAX (8.0)

    MDR report key: 3010330 · Received March 14, 2013

    Report

    Report Number
    3007215625-2013-00017
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    June 27, 2012
    Report Date
    February 15, 2013
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K120023
    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 ADDITIONAL INFORMATION. PER THE PHYSICIAN'S OFFICE THE PROCEDURE WAS CONDUCTED SUCCESSFULLY WITH NO MALFUNCTIONS. ZELTIQ REVIEWED THE SYSTEM LOGS OF THE TREATMENT DATE AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING TREATMENT.

    Description of Event or Problem · 1

    A FEMALE PATIENT RECEIVED COOLSCULPTING TREATMENT WITH THE COOLMAX APPLICATOR (8.0) TO THE LOWER ABDOMEN AND WITH THE COOLCORE APPLICATOR (6.3) ON THE UPPER ABDOMEN ON (B)(6) 2012. ON (B)(6) 2012, ZELTIQ WAS INFORMED THAT THE PATIENT HAD RETURNED TO THE OFFICE ON (B)(6) 2012 AND LOOKED WORSE THAN BEFORE TREATMENT. THE OFFICE ASKED THE PATIENT TO RETURN ON (B)(6) 2012 AT WHICH TIME THEY SAW MILD IMPROVEMENT IN THE UPPER ABDOMEN BUT FELT THE LOWER ABDOMEN STILL LOOKED WORSE. ON (B)(6) 2012, THE PATIENT WAS RE-EVALUATED AND THE LOWER ABDOMEN TISSUE WAS DESCRIBED AS SOFT AND THE SKIN AS LOOSE HAD LAX. THE TREATING PHYSICIAN EXAMINED THE PATIENT ON (B)(6) 2012. HE DESCRIBED THE AREA AS DENSE, RUBBERY, AND THICK. THE PATIENT WAS SEEN BY A PLASTIC SURGEON ON (B)(6) 2013. ZELTIQ RECEIVED A COPY OF THE SURGEON'S NOTE AND ESTIMATE ON (B)(6) 2013 WHICH IDENTIFIED MODERATE SKIN LAXITY, MODERATE LIPODYSTROPHY OF THE LOWER ABDOMEN AS WELL AS FASCIA LAXITY. THE PLASTIC SURGEON RECOMMENDS A MINI TUMMY TUCK, MAKING THIS REPORTABLE. A FOLLOW-UP REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFORMATION IS RECEIVED ABOUT THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108161 ZELTIQ COOLMAX (8.0) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COOLMAX APP. 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention