BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90-2729 CAROTID TRACEPAK

    MDR report key: 361497 · Received November 7, 2001

    Report

    Report Number
    1057373-2001-00002
    Event Type
    Malfunction
    Date Received
    November 7, 2001
    Date of Event
    October 4, 2001
    Report Date
    November 6, 2001
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STAPLE CARTRIDGE SHAFT BROKE OFF THE STAPLE HANDLE DURING A PROCEDURE AND STUCK TO THE PATIENT. THE STAPLER IS A COMPONENT OF THE CAROTID TRACEPAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50041 90-2729 CAROTID TRACEPAK GCPCGROWTH CUST TRACEPAK CARDIOVAS KDD DEROYAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other