BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ EZ APP 8.0

    MDR report key: 2792329 · Received October 12, 2012

    Report

    Report Number
    3007215625-2012-00013
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    April 27, 2012
    Report Date
    September 15, 2012
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    PMA / PMN Number
    K080521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 AND CONFIRMED THAT NO SYSTEM MALFUNCTION OCCURRED DURING TREATMENT. THE PATIENT HAS A HISTORY OF AN UMBILICAL HERNIA REPAIR PRIOR TO HAVING COOLSCULPTING TREATMENT. ON (B)(6) 2012, A BIOPSY FROM THE TREATMENT SITE WAS TAKEN. THE PATHOLOGIST CONCLUDED THAT FINDINGS SUGGEST FIBROSIS AND SCARRING POSSIBLY RELATED TO THE PATIENT¿S HISTORY OF PRIOR SURGERY WITH MESH IN THE AREA.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT A (B)(6) MALE PATIENT RECEIVED ONE COOLSCULPTING TREATMENT WITH THE 8.0 APPLICATOR TO LOWER ABDOMEN. ON (B)(6) 2012, THE TREATING PHYSICIAN INFORMED ZELTIQ THAT ON THE 4 MONTH FOLLOW UP, THE PATIENT¿S TREATED AREA LOOKED LARGER AND FELT DOUGHY. PHOTOS REVEALED TREATED AREA TO BE IRREGULARLY SHAPED. ON (B)(6) 2012, THE PHYSICIAN RECOMMENDED LIPOSUCTION WHICH WAS SUCCESSFULLY PERFORMED ON (B)(6) 2012. 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
    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 48 YR Required Intervention