BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ EZ APP 8.0

    MDR report key: 2534481 · Received April 10, 2012

    Report

    Report Number
    3007215625-2012-00003
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    July 16, 2012
    Report Date
    December 21, 2011
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    PMA / PMN Number
    K080521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT IS ALLEGED THAT A (B)(6) MALE PT RECEIVED COOLSCULPTING TREATMENT ON (B)(6) 2011, PROCEDURE WAS CONDUCTED SUCCESSFULLY. TREATING PHYSICIAN'S OFFICE DID NOT RECALL ANY MALFUNCTIONS OR ERROR CODES. ON (B)(6) 2011, THE OFFICE CONTACTED ZELTIQ TO REPORT THAT DURING FOLLOW UP ON (B)(6) 2011, THE PT CLAIMED THAT THE FATTY TISSUE IN THE TREATMENT AREA HAD INCREASED. THE PHYSICIAN SAW THE PT ON THAT DAY AND REPORTED THAT THE CONDITION WAS INFLAMMATION THAT MAY RESOLVE OVER TIME AND ASKED THE PT TO BE SEEN IN 3 MONTHS. HOWEVER, ON 03/07/2012 ZELTIQ RECEIVED INFORMATION FROM THE PHYSICIAN WHO REPORTED THAT ALTHOUGH THE PT CONDITION'S HAS NOT CHANGED, HE HAS SCHEDULED THE PT FOR SURGERY ON (B)(6) 2012. TREATING PHYSICIAN WAS UNABLE TO ESTABLISH CAUSAL RELATIONSHIP BETWEEN THE TREATMENT AND THE PT'S CONDITION. IT IS ZELTIQ'S POLICY TO BE CONSERVATIVE AND TO MAKE THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZELTIQ EZ APP 8.0 ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS, INC. EZ APP 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention