BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3800252 · Received April 30, 2014

    Report

    Report Number
    1222780-2014-00068
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 31, 2014
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW AND STERILE RECORD REVIEW WERE 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 A PHYSICIAN PERFORMED A "DIFFICULT" NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2014. APPROXIMATELY ONE MONTH LATER, "THE PATIENT PRESENTED [TO THE EMERGENCY ROOM] WITH SEVERE PAIN AND HIGH FEVER. SHE WAS ADMITTED AND PLACED ON BROAD-SPECTRUM ANTIBIOTICS. HER BLOOD CULTURES WERE NEGATIVE BUT ACTINOMYCOSIS WAS IDENTIFIED ON VAGINAL CULTURE. SHE HAD EVIDENCE OF TUBO-OVARIAN ABSCESS ON CT-SCAN AND UNDERWENT A HYSTERECTOMY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258046 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention RADIO FREQUENCY CONTROLLER: SN# UNK