BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLSCULPTING SYSTEM

    MDR report key: 5005991 · Received August 15, 2015

    Report

    Report Number
    3007215625-2015-00003
    Event Type
    Injury
    Date Received
    August 15, 2015
    Report Date
    July 16, 2015
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    PMA / PMN Number
    K151179
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZELTIQ FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADDITIONAL INFORMATION BUT WAS UNABLE TO GET ADDITIONAL INFORMATION ON THE PATIENT, DEVICE, DATE OF TREATMENT, OR DATE OF INCIDENT. DUE TO THE LACK OF INFORMATION, ZELTIQ CANNOT CONFIRM THAT THE EVENT IS RELATED TO THE COOLSCULPTING PROCEDURE. ZELTIQ INFORMED THE COOLSCULPTING PHYSICIAN THAT COOLSCULPTING IS NOT CLEARED FOR TREATMENTS ON THE ARM. THE INTENDED USE FOR THE COOLSCULPTING SYSTEM IS OUTLINED IN THE COOLSCULPTING USER MANUAL. THE USER MANUAL HAS BEEN DISTRIBUTED TO ALL CURRENT AND NEW CUSTOMERS. THE OFFICE REPORTED NO ERRORS OR DEVICE MALFUNCTIONS DURING THE TREATMENT. ZELTIQ WAS NOT ABLE TO OBTAIN THE LOGS FOR THE DEVICE TO CONFIRM THERE WERE NO DEVICE MALFUNCTIONS OR ERRORS.

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW-UP REPORT FOR MDR 3007215625-2015-00003. ON 9/28/2015, ZELTIQ RECEIVED INFORMATION ON THE DEVICE USED.

    Description of Event or Problem · 1

    ON (B)(4) 2015, ZELTIQ WAS INFORMED OF A PATIENT WHO MAY HAVE DEVELOPED A DEEP VEIN THROMBOSIS AFTER COOLSCULPTING TREATMENT. THE TREATING OFFICE REPORTED THAT THE FEMALE PATIENT RECEIVED TREATMENTS ON THE ARM. THE OFFICE HAS NOT INFORMED THE COMPANY OF WHICH APPLICATOR WAS USED AND THE EXACT DATE WHEN THE TREATMENT TOOK PLACE. THE PATIENT INFORMED THE OFFICE THAT SHE HAD SURGERY TO REMOVE THE CLOT IN HER ARM. THE OFFICE REPORTED THAT THE PATIENT WAS APPROXIMATELY ONE MONTH POST-TREATMENT WHEN SHE HAD THE SURGERY. IT HAS NOT BEEN REPORTED WHAT DATE THE SURGERY OCCURRED. THE COOLSCULPTING PHYSICIAN INFORMED ZELTIQ ON (B)(4) 2015 THAT THE TREATING HEMATOLOGIST FELT THAT COOLSCULPTING CAUSED THE CLOT, MAKING THIS REPORTABLE. THE PATIENT IS CURRENTLY ON AN ANTICOAGULANT THERAPY FOR SIX MONTHS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540997 ZELTIQ COOLSCULPTING SYSTEM ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS, INC. COOLFIT APPLICATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention