BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLMAX (8.0)

    MDR report key: 2950096 · Received February 6, 2013

    Report

    Report Number
    3007215625-2013-00015
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    July 1, 2012
    Report Date
    January 17, 2013
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    PMA / PMN Number
    K120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 FOR THE TREATMENT DATE AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING TREATMENT.

    Description of Event or Problem · 1

    A MALE PT IN (B)(6) RECEIVED COOLSCULPTING TREATMENT ON (B)(6) 2012 ON HIS MID-ABDOMEN CENTERED ON THE UMBILICUS WITH THE COOLMAX APPLICATOR (8.0). DURING A FOLLOW-UP VISIT IN (B)(6) 2012, THE TREATING OFFICE NOTICED "TISSUE STIFFENING" IN THE TREATED AREA. THE PT REPORTED THAT HE NOTICED THE LUMP 3 MONTHS POST-TREATMENT. IN (B)(6) 2012, THE PT UNDERWENT A CT SCAN WHICH INDICATED THAT THE LUMP OF TISSUE WAS FAT. ZELTIQ RECEIVED PHOTOS ON (B)(6) 2012 THAT SHOWED A CENTRALIZED ABDOMINAL BULGE THAT WAS GREATER IN SIZE THAN COMPARED WITH BASELINE. ON (B)(6) 2013, ZELTIQ RECEIVED THE CT IMAGE AND HAD IT INDEPENDENTLY REVIEWED BY A RADIOLOGIST WHO AGREED THAT THE LUMP LOOKED LIKE FAT. ON (B)(6) 2013, ZELTIQ WAS NOTIFIED THAT THE PT HAD BEGUN ACCENT ULTRA TREATMENTS TO TREAT THE CONDITION, MAKING THIS CASE 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
    50689 ZELTIQ COOLMAX (8.0) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS, INC. COOLMAX APP. 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention