BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRGFUS EXABLATE

    MDR report key: 4146933 · Received September 24, 2014

    Report

    Report Number
    9615058-2014-00006
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    INSIGHTEC, LTD.
    Product Code
    NRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN DIAGNOSED AND FOUND WITH NO MALFUNCTIONS. SITE DID NOT ALLOW TREATMENT REVIEW YET.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD WOMAN WITH ADENOMYOSIS AND MENOMETRORRHAGIA WAS "COMMERCIALLY" TREATED ON (B)(6) WITH NO REMARKABLE EVENTS. IN HR PAS THE PATIENT UNDERWENT MYOMECTOMY BY LAPAROTOMY AND SEVERAL IVF ATTEMPTS. THREE DAYS POST-TREATMENT ((B)(6) 2014) THE PATIENT COMPLAINT OF ABDOMINAL PAIN AND WAS REFERRED TO THE EMERGENCY ROOM. SHE ARRIVED TO THE ER ON (B)(6) 2014. FOLLOWING DETERIORATION OF HER CONDITION, SHE WAS TAKEN TO EMERGENCY FOR A LAPAROTOMY. IT WAS REPORTED INDIRECTLY TO INSIGHTEC THAT AT LAPAROTOMY FECES WAS FOUND IN THE ABDOMINAL CAVITY BUT NO APPARENT PERFORATION OF PERFORATION SITE WAS DETECTED. THE PATIENT DIES ON (B)(6) 2014. ON (B)(6) PM WAS PERFORMED. AT THIS TIME, THE PM RESULTS ARE NOT AVAILABLE, PER HOSPITAL MANAGEMENT DECISION. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593541 MRGFUS EXABLATE HIFU NRZ INSIGHTEC, LTD. 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death