BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3161574 · Received May 6, 2013

    Report

    Report Number
    1222780-2013-00101
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 7, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. 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. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) OTHER ADVERSE EVENTS: THE FOLLOWING ADVERSE EVENT COULD OCCUR OR HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF THE NOVASURE SYSTEM: INFECTION OR SEPSIS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, A PATIENT HAD A NOVASURE ENDOMETRIAL ABLATION. A POST HYSTEROSCOPY WAS DONE AND A "VERY GOOD BURN OF THE ENDOMETRIAL LINING" WAS SEEN AND "THE PATIENT TOLERATED THE PROCEDURE WELL." THE PATIENT RETURNED TO THE EMERGENCY ROOM THE NEXT DAY ((B)(6) 2013) WITH "ABDOMINAL PAIN, BLOATING, AND A FEVER OF 103 DEGREES" (FAHRENHEIT). SHE WAS ADMITTED AND GIVEN INTRAVENOUS (IV) AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM). CULTURES RETURNED "POSITIVE FOR GRAM NEGATIVE RODS AND E-COLI" (ESCHERICHIA COLI). ROCEPHIN (CEFTRIAXONE) AND VIBRAMYCIN WERE ADDED TO THE TREATMENT REGIME. ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196723 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R RADIO FREQUENCY CONTROLLER: SERIAL #UNK