BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 3650303 · Received February 11, 2014

    Report

    Report Number
    1222780-2014-00020
    Event Type
    Death
    Date Received
    February 11, 2014
    Date of Event
    December 19, 2013
    Report Date
    January 13, 2014
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K100559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. THE DISPOSABLE 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT ABLE TO BE CONDUCTED FOR THE MYOSURE SYSTEM AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN PERFORMED AN UNEVENTFUL MYOSURE FOR UTERINE TISSUE REMOVAL PROCEDURE ON (B)(6) 2013. "[THE] PATIENT WAS NOTED TO NOT BE IN GOOD HEALTH AT THE TIME AND WAS (B)(6) OLD". THE PATIENT RETURNED TO THE EMERGENCY ROOM (E.R.) ON THE EVENING AFTER THE MYOSURE PROCEDURE COMPLAINING OF "SHORTNESS OF BREATH AND CHEST PAINS". THE PATIENT WAS TRANSFERRED INTO A LOCAL AREA HOSP. AND EXPIRED ON (B)(6) 2013. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89937 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HIH HOLOGIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death CONTROL UNIT - SERIAL NUMBER UNK| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM| MYOSURE HYSTEROSCOPE - SERIAL NUMBER UNK| SALINE DISTENTION MEDIA