BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3925302 · Received July 2, 2014

    Report

    Report Number
    1222780-2014-00108
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 5, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) AND STERILE LOT REVIEWS WERE UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICES AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN PERFORMED AN UNEVENTFUL NOVASURE PROCEDURE ON (B)(6) 2014 AND THE PATIENT WAS DISCHARGED HOME. THE PATIENT RETURNED TO THE "EMERGENCY ROOM ON (B)(6) 2014 WITH SEVERE ABDOMINAL PAIN AND TEMPERATURE TO 103 DEGREES FAHRENHEIT. HER WHITE BLOOD CELL COUNT WAS 2.5 AND A COMPUTED TOMOGRAPHY (CT) SCAN WAS OBTAINED WHICH WAS NEGATIVE HOWEVER, NO CONTRAST WAS USED. SHE WAS STARTED ON BOARD SPECTRUM ANTIBIOTICS AND ADMITTED TO THE HOSPITAL. SHE DID NOT HAVE AN CUTE ABDOMEN ON EXAM. HER BLOOD CULTURES GREW OUT (B)(6), [HER] FINAL RESULTS ARE NOT YET AVAILABLE. WITHIN 12 HOURS SHE BECAME AFEBRILE AND HER WHITE BLOOD CELL (WBC) COUNT WAS 12.5. SHE HAS REMAINED A FEBRILE AND HER WBC IS NOW 9.2 WITH IMPROVEMENT IN HER PAIN HOWEVER, SHE CONTINUES TO HAVE RIGHT UPPER QUADRANT DISCOMFORT WHICH IS BEING MONITORED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385381 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R RADIO FREQUENCY CONTROLLER: SN UNK