BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ EZ APP 8.0

    MDR report key: 2645631 · Received June 29, 2012

    Report

    Report Number
    3007215625-2012-00005
    Event Type
    Injury
    Date Received
    June 29, 2012
    Date of Event
    October 28, 2011
    Report Date
    June 18, 2012
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K080521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012 ZELTIQ WAS INFORMED BY THE OFFICE THAT THE PT WAS SEEN ON (B)(6) 2012. THERE HAS NOT BEEN ANY CHANGE (NO IMPROVEMENT OR WORSENING) AND THE PT IS SCHEDULED FOR LIPOSUCTION ON (B)(6) 2012. ON (B)(6) 2012, ZELTIQ WAS NOTIFIED THAT THE PT HAS UNDERGONE LIPOSUCTION ON (B)(6) 2012 ON BOTH THE FLANK AND ABDOMEN. THIS CASE HAS ALSO BEEN REPORTED FOR EZ APP. 6.3 IN MDR 3007215625-2012-00004. A F/U REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFO IS RECEIVED ABOUT THIS CASE.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT A (B)(6) MALE PT RECEIVED COOLSCULPTING TREATMENT WITH THE 8.0 APPLICATOR TO LOWER ABDOMEN ON (B)(6) 2011, ONE TREATMENT WITH 6.3 APPLICATOR TO EACH FLANK ON (B)(6) 2011, AND ONE MORE TREATMENT WITH 6.3 APPLICATOR TO EACH FLANK IN AREA ADJACENT TO THE PREVIOUSLY TREATED AREA ON (B)(6) 2011. ALL THE PROCEDURES WERE CONDUCTED SUCCESSFULLY WITH NO MALFUNCTIONS WHICH WERE CONFIRMED BY REVIEW OF SYSTEM LOGS. ON (B)(6) 2012, THE OFFICE CONTACTED ZELTIQ TO REPORT THAT THE PT CLAIMED THAT THE FATTY TISSUE IN THE TREATMENT AREA HAD INCREASED. THEY INFORMED US THAT AN ULTRASOUND WAS PERFORMED ON THE PT ON (B)(6) 2012 WHICH INDICATED INFLAMMATION OR PANNICULITIS. FOLLOWING WHICH HE HAD A BIOPSY WHICH CONFIRMED PRESENCE OF INFLAMMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention