BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZELTIQ EZ APP 6.3

    MDR report key: 2492313 · Received March 13, 2012

    Report

    Report Number
    3007215625-2012-00001
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    October 25, 2011
    Report Date
    February 13, 2012
    Manufacturer
    ZELTIQ AESTHETICS, INC.
    Product Code
    OOK
    PMA / PMN Number
    K080521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE MADE TO THE AGENCY IF AND WHEN NEW INFO IS RECEIVED ABOUT THIS CASE.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT A (B)(6) FEMALE PT RECEIVED COOLSCULPTING TREATMENT ON UPPER AND LOWER ABDOMEN ON (B)(6) 2011; PROCEDURE WAS CONDUCTED SUCCESSFULLY. TREATING PHYSICIAN'S OFFICE DID NOT RECALL ANY MALFUNCTIONS OR ERROR CODES. PT WAS NOT SEEN OR HEARD AGAIN UNTIL (B)(6) 2012, WHEN SHE CALLED THE OFFICE COMPLAINING ABOUT A DEVELOPMENT OF A BULGE ON THE UPPER ABDOMEN. THE PT HAD AN ABDOMINOPLASTY ON (B)(6) 2012 BY A PLASTIC SURGEON (NOT THE TREATING PHYSICIAN). DURING ABDOMINOPLASTY, DIASTASIS RECTI WAS OBSERVED AND REPAIRED. THERE WAS NO CAUSAL RELATIONSHIP DETERMINED BY THE SURGEON. THERE WAS NO HERNIA PRESENT. THERE WAS NO FAT NECROSIS OBSERVED. THE SURGEON NOTED THAT THE FAT ON THE UPPER ABDOMINAL AREA SEEMED FIRMER THAN THAT OF LOWER ABDOMEN. TREATING PHYSICIAN WAS UNABLE TO ESTABLISH CAUSAL RELATIONSHIP BETWEEN THE TREATMENT AND THE PT'S CONDITION. IT IS ZELTIQ'S POLICY TO BE CONSERVATIVE AND TO MAKE THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other