BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3143059 · Received May 23, 2013

    Report

    Report Number
    1222780-2013-00096
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 23, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AND THS HYSTEROSCOPE 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 REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A NOVASURE ENDOMETRIAL ABLATION WHICH WAS UNEVENTFUL ON (B)(6) 2013, THE PHYSICIAN PERFORMED A DILATATION AND CURETTAGE (D AND C), HYSTEROSCOPY AND A POLYPECTOMY. ON (B)(6) 2013, THE PATIENT RETURNED TO THE FACILITY COMPLAINING OF FLU LIKE SYMPTOMS AND FEVER. THE PATIENT WAS ADMITTED AND REMAINED AT THE FACILITY FOR EIGHT DAYS. "TREATMENT OF ANTIBIOTICS [WAS] RECOMMENDED BY THE PHYSICIAN DURING THIS STAY". THE PATIENT WAS DISCHARGED ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT AGAIN RETURNED TO THE FACILITY COMPLAINING OF FEVER AND FLU LIKE SYMPTOMS. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228680 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization RADIO FREQUENCY CONTROLLER: SERIAL NUMBER UNKNOWN| THS-HYSTEROSCOPE: SERIAL NUMBER UNKNOWN