BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLCURVE (6.2)

    MDR report key: 2850640 · Received November 20, 2012

    Report

    Report Number
    3007215625-2012-00021
    Event Type
    Injury
    Date Received
    November 20, 2012
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K080521
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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

    IT IS ALLEGED THAT A (B)(6) FEMALE PATIENT RECEIVED TWO COOLSCULPTING TREATMENT CYCLES WITH THE COOLCORE (6.3) APPLICATOR TO THE UPPER ABDOMEN ON (B)(6) 2012. ON (B)(6) 2012 THE PATIENT RECEIVED ONE TREATMENT CYCLE TO THE LOWER ABDOMEN WITH THE COOLMAX (8.0) APPLICATOR. IN ADDITION, ON (B)(6) 2012, THE PATIENT RECEIVED TWO TREATMENT CYCLES TO EACH FLANK WITH THE COOLCURVE (6.2) APPLICATOR. POST TREATMENT PHASE WAS UNEVENTFUL. THE TREATING PHYSICIAN REPORTED THAT ON FOLLOW UP ON (B)(6) 2012 THE TREATED TISSUE FELT LIKE FIRM NORMAL FAT. HE DID NOT FEEL THERE WAS ANY FAT NECROSIS OR ANYTHING ODD TO REPORT. ON (B)(6) 2012, THE PHYSICIAN'S OFFICE CALLED TO REPORT THAT THE TREATMENT AREA WAS ENLARGED AND THAT THE PHYSICIAN RECOMMENDED LIPOSUCTION TO REMOVE THE TISSUE FROM TREATED AREA MAKING THIS A REPORTABLE EVENT. THIS CASE HAS ALSO BEEN REPORTED FOR THE COOLCORE APPLICATOR IN MDR 3007215625-2012-00019 AND FOR THE COOLMAX APPLICATOR IN MDR 3007215625-2012-00020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZELTIQ COOLCURVE (6.2) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COOLCURVE APP. 6.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR