BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 9313438 · Received November 12, 2019

    Report

    Report Number
    1222780-2019-00252
    Event Type
    Injury
    Date Received
    November 12, 2019
    Date of Event
    May 19, 2018
    Report Date
    October 23, 2019
    Manufacturer
    HOLOGIC, INC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER INFORMATION OR FACILITY NOT PROVIDED BY COMPLAINANT. 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED OR DEVICE EVALUATION COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS RECEIVED UNDER MW# 5090107. IT WAS REPORTED BY THE PATIENT THAT SHE HAD AN ENDOMETRIAL ABLATION PROCEDURE PERFORMED IN 2018. SINCE THE DAY OF THE PROCEDURE SHE REPORTEDLY HAS BEEN EXPERIENCING SEVERE UTERINE PAIN AND URGENCY OF URINATION. SHE EXPERIENCED CLEAR/ORANGE DISCHARGE FOR ALMOST 2 MONTHS AFTER THE PROCEDURE. NINE WEEKS POST ABLATION THE PATIENT TRIED BEING INTIMATE WITH HER SPOUSE BUT IT WAS EXTREMELY PAINFUL. SHE EXPERIENCED RADIATING BODY WIDE PAIN. PERFORMING PHYSICIAN SAW THE PATIENT IN CLINIC AND STATES "IT LOOKED NORMAL" AFTER A PHYSICAL EXAM. PATIENT STATES SHE SAW RED AND PURPLE INFLAMED STREAKS THROUGHOUT THE VULVAR AND RECTAL AREA. PATIENT'S GENERAL PRACTITIONER STATES THAT THIS IS A FIBROMYALGIA FLAREUP. ANOTHER GENERAL PRACTITIONER REFERRED THE PATIENT TO A GASTROENTEROLOGIST WHO SUGGESTED THE USE OF HYDROCORTISONE CREAM ON THE RECTAL AREA. PATIENT STATES THAT INTIMACY IS IMPOSSIBLE AND THAT SHE HAS "BURNED FISSURES IN MY RECTAL AND VAGINAL AREA THAT WILL NOT HEAL" AND THAT SHE IS "COMPLETELY DEBILITATED." PATIENT ALSO STATES THAT SHE FEELS LIKE SHE IS GOING TO START TO MENSTRUATE (CRAMPING) BUT EXPERIENCES NO BLEEDING, ONLY SEVERE PELVIC SWELLING AND PAIN FOR SEVERAL DAYS. SHE BELIEVES SCAR TISSUE HAS PLUGGED HER CERVIX. PATIENT HAS BEEN TO A GYNECOLOGIST TWICE, THE ER TWICE, URGENT CARE TWICE, 5 GENERAL PRACTITIONERS, A GASTROENTEROLOGIST, A DERMATOLOGIST, AND A GENERAL SURGEON AND NO ONE HAS BEEN ABLE TO HELP HER. NO ADDITIONAL DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102648 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM UTERINE ABLATION DEVICE MNB HOLOGIC, INC NS2007 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other