BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLCORE (6.3)

    MDR report key: 2860495 · Received December 5, 2012

    Report

    Report Number
    3007215625-2012-00024
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    December 23, 2011
    Report Date
    October 30, 2012
    Manufacturer
    ZELTIQ AESTHETICS INC.
    Product Code
    OOK
    PMA / PMN Number
    K080521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT A (B)(6) FEMALE PATIENT RECEIVED ONE COOLSCULPTING TREATMENT CYCLE ON THE LEFT BRA FAT SITE ON (B)(6) 2011 WITH THE COOLCORE (6.3) APPLICATOR. THE BRA FAT AREA WAS REPORTEDLY ENLARGED AFTER TREATMENT. THE PHYSICIAN REPORTED THAT THE TREATED AREA IS FIRMER THAN SURROUNDING TISSUE AND THE CONTRALATERAL SIDE. ON (B)(6) 2012, THE TREATING PHYSICIAN ATTEMPTED A MICROCANNULAR LIPOSUCTION AND FOUND THE FAT TO BE MORE FIBROUS THAN THE UNTREATED SIDE. ULTRASOUND PERFORMED ON (B)(6) 2012 SHOWED NORMAL FAT TISSUE. ON (B)(6) 2012, THE PHYSICIAN PERFORMED ON INTRALESIONAL INJECTION WITH 4CC OF 2.5% KENALOG BUT THE CONDITION DID NOT IMPROVE. ON (B)(6) 2012, ZELTIQ WAS INFORMED THAT THE PHYSICIAN RECOMMENDED SURGICAL EXCISION OF THE ENLARGEMENT MAKING THIS A REPORTABLE EVENT. ZELTIQ WAS INFORMED OF THIS CASE ON (B)(6) 2012 IN A PHONE CALL WITH THE TREATING PHYSICIAN AND SUBSEQUENTLY RECEIVED A CLINICAL EVENT FORM WITH DETAILED INFORMATION ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZELTIQ COOLCORE (6.3) ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS INC. COOLCORE APP. 6.3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention