BEUDAMED
    FDA Adverse Event Other Summary report: N

    90-0143 CAB FN TRACEPAK

    MDR report key: 467668 · Received June 20, 2003

    Report

    Report Number
    2320762-2003-00001
    Event Type
    Other
    Date Received
    June 20, 2003
    Date of Event
    May 14, 2003
    Report Date
    May 14, 2003
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON COMPLAINED THAT DURING OPEN HEART SURGERY THE GOWNS, 5-15926 WERE ALLOWING "BLOOD STRIKE THROUGH" TO OCCUR. THE GOWNS THE SURGEON WAS USING ARE ASSEMBLED IN CONVENIENCE KITS 50-10837 ENCLOSED IN 90-0143 CAB FN TRACEPAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 90-0143 CAB FN TRACEPAK GOWN-CONVENIENCE KIT KDD DEROYAL INDUSTRIES, INC. NA 753658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other