BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3212723 · Received June 28, 2013

    Report

    Report Number
    1222780-2013-00127
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    DURING A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2013, THE CAVITY INTEGRITY ASSESSMENT (CIA) TEST WAS UNSUCCESSFUL. THE PHYSICIAN USED A SECOND DISPOSABLE DEVICE AND COMPLETED THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME. LATER THE SAME DAY THE PATIENT RETURNED TO THE EMERGENCY ROOM (ER) WITH "PAINS AND FEVER". THE PATIENT WAS ADMITTED AND RECEIVED TREATMENT (TREATMENT UNKNOWN). IT IS UNKNOWN WHEN THE PATIENT WAS DISCHARGED. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296136 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 13A30R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK