BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE REACH TISSUE REMOVAL DEVICE

    MDR report key: 17515538 · Received August 11, 2023

    Report

    Report Number
    1222780-2023-00272
    Event Type
    Death
    Date Received
    August 11, 2023
    Date of Event
    April 28, 2023
    Report Date
    August 11, 2023
    Manufacturer
    HOLOGIC, INC
    Product Code
    HIH
    PMA / PMN Number
    K152723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC IS SUBMITTING THIS REPORT IN ACCORDANCE WITH 21. CFR PART 803. THE SUBMISSION IS BASED UPON THE CURRENTLY AVAILABLE INFORMATION. THE SUBMISSION OF THIS REPORT DOES NOT REPRESENT A CONFIRMATION OF DEVICE MALFUNCTION INVOLVING THE HOLOGIC PRODUCTS IN THE EVENT DESCRIBED. D4: LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE 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. H3: 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 · 0

    IT WAS REPORTED THAT ON (B)(6), A MYOSURE PROCEDURE WAS PERFORMED, THE PATIENT WAS ELDERLY AND FRAIL AND HAD A BOWEL PERFORATION AFTER THE PROCEDURE. THE PATIENT WASN¿T ELIGIBLE FOR SURGERY DUE TO AGE AND CO-MORBIDITIES, THEREFORE THE SURGEONS DECIDED NOT TO OPERATE AND TREAT CONSERVATIVELY WITH ANTIBIOTICS. THESE DID NOT WORK AND RESULTED IN DEATH. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117403 MYOSURE REACH TISSUE REMOVAL DEVICE HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC 10-401FC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death