BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRH O'REGAN SYSTEM

    MDR report key: 3695314 · Received March 11, 2014

    Report

    Report Number
    9615917-2014-00001
    Event Type
    Death
    Date Received
    March 11, 2014
    Report Date
    March 3, 2014
    Manufacturer
    CRH MEDICAL PRODUCTS CORPORATION
    Product Code
    FHN
    PMA / PMN Number
    K963166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UNK, EVENT WAS REPORTED AND FOUND BY CRH ON THE MAUDE DATABASE, MAUDE DATABASE VIA A ROUTINE SEARCH ON (B)(4) 2014 AND A FOLLOW UP MAUDE EVENT REPORT WAS RECEIVED FROM FDA SHORTLY AFTER INDICATING A DEATH WAS REPORTED IN ASSOCIATION WITH THE CRH LIGATOR. INFO WAS REVIEWED AND THE SOURCE OF THE REPORT WAS IDENTIFIED. EXACT DETAILS ARE UNK AS IT WAS REPORTED BY A MEDICAL EXAMINER'S OFFICE, REQUESTS WERE MADE TO OBTAIN THE EXAMINER'S REPORT UNDER THE FREEDOM OF INFO ACT. PT INFO AND CAUSE OF DEATH WAS OBTAINED FROM THE REPORT, CAUSE OF DEATH WAS SEPTIC SHOCK DUE TO ACUTE PERITONITIS, A CONTRIBUTORY CAUSE WAS LISTED AS HEMORRHOIDAL. REVIEW OF THE DETAILS OF THE REPORT DO NOT INDICATE ANY TRAUMA/BREACH/ THAT WOULD BE ATTRIBUTED TO THE LIGATOR. DELAYS IN REPORTING THE INCIDENT WERE CAUSED BY REVIEWING THE ORIGINAL INFO RECEIVED AGAINST THE DEVICE DESIGN/USE AND IN CONJUNCTION WITH THE NEWLY OBTAINED INFO FROM THE AUTOPSY REPORT. THE CLINIC THAT ORIGINALLY CONDUCTED THE PROCEDURE HAD INDICATED THERE WAS NOTHING RELATED TO THE DEVICE THAT OCCURRED DURING THE PROCEDURE. NO ANOMALIES IN PHYSICAL CHARACTERISTICS OF THE DEVICE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145380 CRH O'REGAN SYSTEM LIGATOR FHN CRH MEDICAL PRODUCTS CORPORATION 11-4020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death