BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 813129 · Received February 5, 2007

    Report

    Report Number
    MW1041869
    Event Type
    Other
    Date Received
    February 5, 2007
    Date of Event
    January 30, 2007
    Report Date
    February 5, 2007
    Manufacturer
    TRIAGE MEDICAL INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REMOVAL OF ACCESS SHEATH, THE SHEATH BROKE INTO 2 PIECES. PHYSICIAN WAS ABLE TO REMOVE BOTH PIECES FROM THE PT. NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TELEPORT .11 MM I.D. ACCESS SHEATH DYB TRIAGE MEDICAL INC 9044 112706-A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other