BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COLLMAX (8.0)

    MDR report key: 3023853 · Received March 26, 2013

    Report

    Report Number
    3007215625-2013-00019
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    November 1, 2011
    Report Date
    February 27, 2013
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K120023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THIS CASE, ZELTIQ WAS CONTACTED BY THE PT WHO WISHED TO REMAIN ANONYMOUS. AS SUCH, ZELTIQ WAS UNABLE TO OBTAIN SYSTEM LOGS AND APPLICATOR SERIAL NUMBER FROM THE PHYSICIAN'S OFFICE. THE PT REPORTED THAT THE TREATMENTS WERE UNEVENTFUL. A FOLLOW-UP REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFO IS REC'D ABOUT THIS CASE.

    Description of Event or Problem · 1

    A MALE PT INFORMED ZELTIQ THAT HE REC'D COOLSCULPTING TREATMENT IN (B)(6) 2011 WITH THE COOLMAX APP (8.0) ON HIS LOWER ABDOMEN. IN (B)(6) 2011, THE PT NOTICED THE AREA WAS LARGER. BY (B)(6) 2012, THE ENLARGEMENT WAS STILL PRESENT. THE PT REPORTED THAT THE BULGE WAS FIRMER THAN THE SURROUNDING AREA. IN (B)(6) 2012, THE PT HAD A SECOND TREATMENT TO THE SAME AREA. THE BULGE INITIALLY DECREASED BUT INCREASED AGAIN 6-8 WEEKS AFTER THE SECOND TREATMENT. THE PT DESCRIBED THE AREA AS FIRMER THAN SURROUNDING TISSUES. THE PT VISITED A PLASTIC SURGEON ON (B)(6) 2012 WHO RECOMMENDED POSSIBLE TREATMENT OPTIONS INCLUDING ULTRASOUND TREATMENTS, VIBRATORY TREATMENTS, OR LIPOSUCTION. THE PT CHOSE TO TRY VIBRATORY TREATMENTS WITH AN OTC PERSONAL MASSAGER. ON (B)(6) 2012, THE PT VISITED ANOTHER PHYSICIAN WHO RECOMMENDED THE PT STOP MASSAGING THE AREA BUT INSTEAD TRY 60% DMSO AND MEDICAL ULTRASOUND ONCE A WEEK. ON (B)(6) 2013, THE PT WAS EXAMINED BY THE TREATING PHYSICIAN WHO DETERMINED THAT THE PT'S CONDITION WILL NOT RESOLVE ON ITS OWN AND WILL NEED SURGICAL INTERVENTION, MAKING THIS CASE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123470 ZELTIQ COLLMAX (8.0) ZELTIQ VACUUM APLICATOR OOK ZELTIQ AESTHETICS INC. COOLMAX APP. 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention