BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRETTA 8800 CATHETER AND ACCESSORIES KIT

    MDR report key: 8864642 · Received August 5, 2019

    Report

    Report Number
    MW5088763
    Event Type
    Death
    Date Received
    August 5, 2019
    Date of Event
    October 2, 2018
    Report Date
    August 2, 2019
    Manufacturer
    MEDERI THERAPEUTICS / MEDERI RF LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE PT UNDERWENT A STRETTA PROCEDURE WITH A DEVICE MANUFACTURED BY MEDERI THERAPEUTICS, INC. THERE WERE NO APPARENT COMPLICATIONS. THE FOLLOWING DAY THE PT WAS ADMITTED TO A DIFFERENT HOSP AND ULTIMATELY DIES OF SEPSIS. UPON INVESTIGATION, IT WAS DETERMINED THAT REPORTING SHOULD OCCUR DUE TO THE POSSIBILITY THAT THE PT'S DEATH MAY BE DEVICE RELATED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657025 STRETTA 8800 CATHETER AND ACCESSORIES KIT ELECTROSURGICAL, CUTTING & COAGULATION GEI MEDERI THERAPEUTICS / MEDERI RF LLC ME110900009

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death