BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ EZ APP 8.0

    MDR report key: 2842068 · Received November 12, 2012

    Report

    Report Number
    3007215625-2012-00017
    Event Type
    Injury
    Date Received
    November 12, 2012
    Date of Event
    August 19, 2011
    Report Date
    October 22, 2012
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K080521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZELTIQ FOLLOWED UP WITH THE PHYSICIAN'S OFFICE TO GATHER ADDITIONAL INFO. PER THE PHYSICIAN'S OFFICE, THE PROCEDURE WAS CONDUCTED SUCCESSFULLY WITH NO MALFUNCTIONS. ZELTIQ REVIEWED THE SYSTEM LOGS AND CONFIRMED THAT NO SYS MALFUNCTION OCCURRED DURING TREATMENT.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT A (B)(6) FEMALE PT RECEIVED ONE COOLSCULPTING TREATMENT CYCLE WITH AN EZ 8.0 APPLICATOR TO LOWER ABDOMEN ON (B)(6) 2011. IN (B)(6) 2011, THE PT FOUND THAT THE RESPONSE TO TREATMENT WAS UNEVEN AND WAS RETREATED ON (B)(6) 2011, WITH ONE TREATMENT CYCLE WITH THE EZ 8.0 APPLICATOR. ADDITIONALLY, THE PT RECEIVED TREATMENT ON BOTH SIDES OF HER ABDOMEN VERTICALLY WITH EZ 6.3 APPLICATOR. ON (B)(6) 2012, PT CONTACTED ZELTIQ TO COMPLAIN THAT HER TREATMENTS HAD CAUSED THE TISSUE IN THE TREATMENT AREA TO BECOME FIRM, WHICH WAS LATER CONFIRMED BY THE TREATMENT PHYSICIAN ON (B)(6) 2012. ON ZELTIQ RECOMMENDATION, THE PT UNDERWENT MRI ON (B)(6) 2012. THE TESTING REPORT RECEIVED ON (B)(4) 2012 INDICATED NORMAL SUBCUTANEOUS FAT; NO INFLAMMATION; NO FOCAL MASS; NO ENHANCEMENT OF THE ABDOMINAL SUBCUTANEOUS FAT. ON (B)(6) 2012, THE PT SAW A PLASTIC SURGEON FOR A CONSULTATION. THE PHYSICIAN RECOMMENDS A MINI ABDOMINOPLASTY TO LOWER ABDOMINAL AND LIPOSUCTION TO UPPER ABDOMEN MAKING THIS A REPORTABLE EVENT. THIS CASE HAS ALSO BEEN REPORTED FOR EZ APP 6.3 IN MDR 3007215625-2012-00018.

    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 32 YR Required Intervention