BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAINLESS STEEL WIRES

    MDR report key: 18815329 · Received February 29, 2024

    Report

    Report Number
    MW5152190
    Event Type
    Death
    Date Received
    February 29, 2024
    Date of Event
    December 12, 2023
    Report Date
    February 26, 2024
    Manufacturer
    UNK
    Product Code
    GAQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BROTHER HAD HEART VALVE REPLACEMENT SURGERY ON (B)(6) 2023 AT MEDICAL CENTER IN (B)(6). HE GOT A VERY SEVERE CASE OF INFECTION IN CHEST, BLOOD AND LUNGS. DOCTORS WERE TOLD THAT HE HAD A FAMILY GENETIC HISTORY OF REJECTING FOREIGN OBJECTS. BUT THEY IGNORED THIS INFORMATION. HIS ONLY KIDNEY WAS FAILING AND ALL THE ANTIBIOTICS WERE NOT HELPING! THE STAINLESS STEEL WIRES IN PLATE USED TO KEEP CHEST CLOSED BECAME LOOSE AND WAS REPLACED WITH ANOTHER STAINLESS STEEL CABLE INSTEAD OF A TITANIUM ONE. AFTER SECOND STAINLESS PLATE, INFECTION BECAME EVEN MORE SEVERE WITH IT SHATTERING HIS CHEST BONE AND ANOTHER SURGEON REMOVING IT BECAUSE SURGEON WHO PERFORMED SURGERY LEFT FOR VACATION! HIS BRAIN WAS STILL ACTIVE BUT THEY EVENTUALLY REMOVED HIS BREATHING TUBE AND GAVE HIM HIGH DOSES OF MORPHINE AND LET HIM DIE!! THIS DEVICE THAT WAS USED HAS A HIGH RATE OF INFECTION FOR NORMAL PEOPLE AND EVEN MORE FOR SOMEONE WITH FAMILY GENETIC ISSUES. IT SHOULD BE PULLED FROM THE MARKET. MULTIPLE SAMPLES OF BLOOD AND SPUTUM PROVED INFECTIOUS. REF REPORTS: MW5152189, MW5152191, AND MW5152192.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322316 STAINLESS STEEL WIRES SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE GAQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Death