BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRAIN, FLAT, 10X4MM, PERFORATED

    MDR report key: 257726 · Received January 7, 2000

    Report

    Report Number
    1423507-2000-00005
    Event Type
    Malfunction
    Date Received
    January 7, 2000
    Date of Event
    December 7, 1999
    Report Date
    January 7, 2000
    Product Code
    GCY
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATES DURING REMOVAL OF FLAT DRAIN, PART OF THE DRAIN BROKE IN PT. PT RETURNED TO SURGERY FOR REMOVAL. PART COULD NOT BE REMOVED.

    Description of Event or Problem · 1

    ALLEGIANCE HEALTHCARE CORP HAS DETERMINED THROUGH AN INTERNAL AUDIT PROCESS THAT THE TWO FILES LISTED ABOVE ARE DUPLICATE COMPLAINTS. THE FIRST WAS FILED DIRECTLY FROM THE HOSP WHILE THE SECOND COMPLAINT WAS INITIATED BASED ON NOTIFICATIONOF A LITIGATION FILED BY THE PLAINTIFF'S ATTORNEY. BASED UPON THE INFO, CO HAS CHOSEN TO MAKE 1423507-2001-00016 A DUPLICATE COMPLAINT OF 1423507-2000-00005 AND WILL MAKE THE SECOND A NON-COMPLAINT IN THE CO'S COMPLAINT SYSTEM. ALL INFO FROM BOTH COMPLAINTS HAS BEEN COMBINED TO CREATE ONE SEPARATE FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN, FLAT, 10X4MM, PERFORATED WOUND DRAIN GCY SU130-1311 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention