BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTA

    MDR report key: 58353 · Received September 27, 1996

    Report

    Report Number
    2242551-1996-00003
    Event Type
    Malfunction
    Date Received
    September 27, 1996
    Date of Event
    August 23, 1996
    Report Date
    August 23, 1996
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT #2529252-1996-2.

    Description of Event or Problem · 1

    THE RUBBER VALVE IN THE INTRODUCER LOOSENED AND CAME OUT OT THE BOTTOM OF THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSERTA PERCUTANEOUS INTRODUCER DYB VITAL SIGNS, INC. 8.5F OR 9F F53914 OR F65345

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other