BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED DISPOSABLE INSUFFLATION NEEDLE

    MDR report key: 968669 · Received December 21, 2007

    Report

    Report Number
    1320894-2007-00165
    Event Type
    Malfunction
    Date Received
    December 21, 2007
    Date of Event
    November 16, 2007
    Report Date
    December 20, 2007
    Manufacturer
    CONMED CORPORATION
    Product Code
    FHO
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "NEEDLE FELL APART WHEN BEING PULLED OUT. NONE OF THE PIECES WERE LEFT IN THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED DISPOSABLE INSUFFLATION NEEDLE DISPOSABLE INSUFFLATION NEEDLE FHO CONMED CORPORATION NA 0703301

    Patients

    Seq Age Sex Outcome Treatment
    1 YR