BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE

    MDR report key: 11047431 · Received December 21, 2020

    Report

    Report Number
    11047431
    Event Type
    Death
    Date Received
    December 21, 2020
    Date of Event
    December 12, 2020
    Report Date
    December 12, 2020
    Manufacturer
    ETHICON, LLC
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RENAL TRANSPLANT COMPLETED. ALL INDICATORS ARE THAT THE PROCEDURE WENT WELL. THE PATIENT WAS DISCHARGED FOUR DAYS LATER. TWO DAYS AFTER DISCHARGED, PATIENT PRESENTED TO ED (EMERGENCY DEPARTMENT). DX (DIAGNOSIS) WITH HEMORRHAGE. IT IS BELIEVED THAT A SUTURE EITHER TORE OR BECAME DEFECTIVE LEADING TO A SIGNIFICANT BLEED CULMINATING IN DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515315 PROLENE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON, LLC 8776H QJBDQX

    Patients

    Seq Age Sex Outcome Treatment
    1 13870 DA Death