BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 8937997 · Received August 27, 2019

    Report

    Report Number
    1222780-2019-00201
    Event Type
    Death
    Date Received
    August 27, 2019
    Date of Event
    July 26, 2019
    Report Date
    August 1, 2019
    Manufacturer
    HOLOGIC, INC
    Product Code
    HIH
    PMA / PMN Number
    K152723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: DATE OF DEATH IS UNKNOWN. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXPIRATION DATE IS NOT KNOWN. THE DEVICE HAS NOT YET BEEN RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THE DEVICE IS RETURNED AND 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019 A MYOSURE DEVICE WAS USED FOR AN UNCOMPLICATED INTRAUTERINE FIBROID REMOVAL. THE PHYSICIAN THEN PERFORMED AN ABDOMINAL MYOMECTOMY WITH NON-HOLOGIC PRODUCTS. THE TOTAL PROCEDURE WAS 4-5 HOURS LONG. ON (B)(6) 2019 A HOLOGIC REPRESENTATIVE WAS MADE AWARE THAT THE PATIENT HAD PASSED AWAY. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE ABDOMINAL MYOMECTOMY WAS PROLONGED AND COMPLICATED BY SIGNIFICANT BLEEDING THAT REQUIRED MULTIPLE BLOOD TRANSFUSIONS. ATTEMPTS TO OBTAIN FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730389 MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL SYSTEM UTERINE TISSUE REMOVAL SYSTEM HIH HOLOGIC, INC 10-401FC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death