BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ COOLCORE

    MDR report key: 5043756 · Received August 31, 2015

    Report

    Report Number
    3007215625-2015-00004
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    May 21, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    PMA / PMN Number
    K142491
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OFFICE REPORTED NO ERRORS OR DEVICE MALFUNCTIONS DURING THE TREATMENT. ZELTIQ REVIEWED THE SYSTEM LOGS FOR THE TREATMENT DATE AND CONFIRMED THAT NO SYSTEM MALFUNCTION OR ERRORS OCCURRED DURING THE TREATMENT. TREATMENT IN A PATIENT WITH A HERNIA IN OR ADJACENT TO THE TREATMENT SITE IS CURRENTLY LISTED AS A WARNING IN THE COOLSCULPTING USER MANUAL. IN ADDITION, HERNIA IS LISTED IN THE USER MANUAL AS A POSSIBLE RARE SIDE EFFECT. THE USER MANUAL HAS BEEN DISTRIBUTED TO ALL CURRENT AND NEW CUSTOMERS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, ZELTIQ WAS INFORMED OF A MALE PATIENT WHO DEVELOPED TWO HERNIAS IN THE LOWER ABDOMEN AFTER COOLSCULPTING TREATMENT ON (B)(6) 2015. THE PATIENT WAS TREATED WITH THE COOLCORE APPLICATOR TO THE LOWER LEFT AND LOWER RIGHT ABDOMEN. THE TREATING OFFICE SAID A VISUAL AND PHYSICAL ASSESSMENT WAS DONE PRIOR TO TREATMENT AND FELT NOTHING IN THE TREATMENT AREA. THE PATIENT DID NOT STATE WHEN THE SYMPTOMS FOR HIS HERNIAS BEGAN, BUT HE INFORMED THE TREATING OFFICE OF HIS CONDITION ON (B)(6) 2015. THE TREATING OFFICE INFORMED ZELTIQ ON (B)(6) 2015 OF ITS OPINION THAT THE TWO HERNIAS WERE A PREEXISTING CONDITION. HOWEVER THE TREATING OFFICE DID NOT KNOW IF THE COOLSCULPTING PROCEDURE MAY HAVE EXACERBATED ONE OF THE EXISTING HERNIAS, MAKING THIS REPORTABLE. THE PATIENT HAD SURGERY TO REPAIR THE HERNIAS AND IS RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575201 ZELTIQ COOLCORE ZELTIQ VACUUM APPLICATOR OOK ZELTIQ AESTHETICS, INC. COOLCORE

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention