BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLMAX (8.0)

    MDR report key: 2912791 · Received January 8, 2013

    Report

    Report Number
    3007215625-2013-00003
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    April 1, 2012
    Report Date
    December 10, 2012
    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

    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.

    Description of Event or Problem · 1

    ZELTIQ RECEIVED A CALL FROM A FEMALE PATIENT ON (B)(6) 2012. THE PATIENT RECEIVED COOLSCULPTING TREATMENT ON (B)(6) 2011 WITH THE COOLMAX APPLICATOR (8.0) ON HER LOWER ABDOMEN. THE PATIENT DESCRIBED THAT APPROXIMATELY 4-5 MONTHS POST-PROCEDURE, HER ABDOMEN SEEMED TO BE "HARD." THE PATIENT FOLLOWED UP WITH A PLASTIC SURGEON WHO RECOMMENDED LIPOSUCTION OR ABDOMINOPLASTY. DURING THE INITIAL CONTACT, THE PATIENT ALSO INFORMED ZELTIQ THAT SHE PLANNED TO HAVE LIPOSUCTION TO TREAT THE CONDITION. ZELTIQ CONTACTED THE TREATING OFFICE AND THE PLASTIC SURGEON FOR FOLLOW-UP. ON (B)(6) 2012, ZELTIQ RECEIVED CORROBORATING INFORMATION FROM THE TREATING OFFICE THAT THE PATIENT HAD LIPOSUCTION ON (B)(6) 2012, MAKING THIS A REPORTABLE EVENT. 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
    10318 ZELTIQ COOLMAX (8.0) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COOLMAX APP. 8.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention