BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLCORE (6.3)

    MDR report key: 2924783 · Received January 17, 2013

    Report

    Report Number
    3007215625-2013-00011
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    March 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZELTIQ FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADDITIONAL INFORMATION. IN ADDITION TO THE PREVIOUSLY DESCRIBED TREATMENTS, THE PATIENT WAS TREATED ON THE UPPER ABDOMEN WITH THE 6.3 APP ON (B)(6) 2011 AND WITH THE 8.0 APP ON (B)(6) 2012. THE TREATMENTS WERE UNEVENTFUL AND THE PATIENT HAS HAD NO REPORTED ISSUES IN THAT TREATMENT AREA. PER THE PHYSICIAN'S OFFICE THE PROCEDURES WERE CONDUCTED SUCCESSFULLY WITH NO MALFUNCTIONS. IT IS ZELTIQ'S POLICY TO BE CONSERVATIVE AND TO 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

    A MALE PATIENT IN (B)(6) RECEIVED COOLSCULPTING TREATMENT WITH THE COOLCORE APPLICATOR (6.3) ON THE FLANKS AND LOWER ABDOMEN AND WITH THE COOLMAX APPLICATOR (8.0) ON THE LOWER ABDOMEN ON VARIOUS DATES. THE LOWER ABDOMEN WAS TREATED WITH THE 6.3 APP ON (B)(6) 2010, (B)(6) 2011 AND WITH THE 8.0 APP ON (B)(6) 2012. THE FLANKS WERE TREATED WITH THE 6.3 APP ON (B)(6) 2010, (B)(6) 2011, AND (B)(6) 2012. ON (B)(6) 2012, ZELTIQ WAS INFORMED THAT THE PATIENT BEGAN TO NOTICE AN ENLARGEMENT OF THE FLANKS AND LOWER ABDOMEN 6-8 MONTHS PRIOR. ON (B)(6) 2012, ZELTIQ WAS PROVIDED PHOTOS OF THE PATIENT FROM (B)(6) 2011 THAT INDICATED AN ENLARGEMENT. THE TREATING PHYSICIAN DESCRIBED THE TISSUE AS FIRM. ON (B)(6) 2012, THE TREATING PHYSICIAN INFORMED ZELTIQ THAT AN ULTRASOUND WAS COMPLETED BUT NOT MUCH COULD BE SEEN DUE TO THE HIGH DENSITY TISSUE. ON (B)(6) 2012, AN INDEPENDENT PLASTIC SURGEON REVIEWED THE CASE AND DETERMINED THAT THE CONDITION WAS LIKELY PERMANENT, MAKING THIS REPORTABLE. THIS CASE HAS ALSO BEEN REPORTED FOR COOLMAX APP (8.0) IN MDR 3007215625-2013-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26507 ZELTIQ COOLCORE (6.3) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COOLCORE APP. 6.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention