BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2071824 · Received April 22, 2011

    Report

    Report Number
    1222780-2011-00073
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 25, 2011
    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 EXP 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 RECORDS REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE AS IDENTIFICATION NUMBERS WERE 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. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. IF ADD'L RELEVANT INFO IS RECEIVED OR DEVICE EVAL COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    APPROX 24 HOURS FOLLOWING AN UNEVENTFUL NOVASURE ENDOMETRIAL ABLATION, PERFORMED ON (B)(6) 2011, THE PT REPORTED A "SMELLY DISCHARGE." THE PHYSICIAN PRESCRIBED MEDICATION (DRUG UNK). "ON OR AROUND (B)(6) 2011 OR (B)(6) 2011, THE PT CONTINUED TO COMPLAIN OF A DISCHARGE AS WELL AS PAIN." IT WAS REPORTED THAT THE PHYSICIAN ASKED THE PT TO GO TO THE HOSPITAL WHERE, AS OF (B)(6) 2011, SHE IS "UNDER OBSERVATION." DURING OUR FOLLOW UP ON (B)(6) 2011, IT WAS REPORTED THAT "THE PT IS PRESENTLY OK." WE HAVE BEEN UNABLE TO OBTAIN ADD'L INFO SURROUNDING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK