BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS 25 INFLOW TUBE SET

    MDR report key: 1641038 · Received March 22, 2010

    Report

    Report Number
    3003604053-2010-00004
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    January 20, 2010
    Report Date
    February 17, 2010
    Manufacturer
    ANDOVER MANUFACTURING SITE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    LEAK WAS FOUND SOON AFTER SURGERY STARTED. A HOLE WAS FOUND IN THE CENTER OF THE LEFT MEMBRANE. FLUID SPRAYED OUT FROM THAT HOLE WHEN IT WAS CHECKED. SURGERY WAS DISCONTINUED. THE CASE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS 25 INFLOW TUBE SET DYONICS 25 INFLOW TUBE SET / NBH NBH ANDOVER MANUFACTURING SITE 7211004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1