BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVASURE

    MDR report key: 12308212 · Received August 11, 2021

    Report

    Report Number
    1222780-2021-00223
    Event Type
    Death
    Date Received
    August 11, 2021
    Date of Event
    July 20, 2021
    Report Date
    August 10, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    UDI-DI
    15420045508224
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT/SERIAL NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS. WE ARE CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON JULY 23RD, 3 DAYS AFTER A NOVASURE PROCEDURE A PATIENT DIED. DURING THE PROCEDURE THE PATIENT RECEIVED STANDARD DOSE OF PROPOFOL ACCORDING TO HER WEIGHT WHICH WAS (B)(6) WITH A BMI OF 43.6. ADDITIONALLY, A LARYNX MASK WAS USED TO MAINTAIN GOOD OXYGEN SATURATION. THE PATIENT HAD NO HISTORY OF THROMBOSIS. NO THROMBOPHILIA OR ANTIPHOSPHOLIPID SYNDROMED DIAGNOSED IN THE PAST. THE PATIENT HAD A HISTORY OF CHRONIC HYPERTENSION AND RECEIVED ATENOLOL 50 MG DAILY (25 MG 2 TIMES A DAY) AND BIPRETERAX 5 MG ONCE PER DAY. FOR HIGH CHOLESTEROL THE PATIENT WAS TAKING SIMVASTATIN 20 MG ONCE DAILY. ON THE DAY OF THE PROCEDURE THE PATIENT RECEIVED A IRON SUPPLEMENT OF 100 MG ONCE FOR ANEMIA AND 6 HOURS AFTER THE PROCEDURE THE PATIENT RECEIVED A SINGLE DOSE OF CLEXANE 0.4 ML. IT WAS REPORTED THAT THE PATIENT STAYED ONE NIGHT AFTER THE PROCEDURE AT THE HOSPITAL DUE TO HOSPITAL POLICY. THE PROBABLE CAUSE FOR THE DEATH WAS PULMONARY EMBOLISM, THE INVESTIGATION IS STILL UNDERGOING AT THE TIME OF THIS REPORT. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204125 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. 2013 21B23RU 15420045508224

    Patients

    Seq Age Sex Outcome Treatment
    1 Death