BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE DIAMETER LACRIMAL INTUBATION SET/ STENTUBE

    MDR report key: 880557 · Received October 11, 2006

    Report

    Report Number
    1649914-2006-00092
    Event Type
    Malfunction
    Date Received
    October 11, 2006
    Report Date
    October 10, 2006
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    HNW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE SURGEON HAD TWO STEN TUBES BREAK WHERE THE SILICONE TUBE CONNECTS TO THE METAL. NO PT COMPLICATIONS WERE REPORTED. ONE SAMPLE WAS SAVED AND WILL BE RETURNED TO QUEST. PRODUCT CODE LIS052; LOT NUMBER 26275.H04.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE DIAMETER LACRIMAL INTUBATION SET/ STENTUBE MANUAL OPHTHALMIC SURGICAL INSTRUMENT: LACRYMAL PROBE HNW QUEST MEDICAL, INC. LIS052 22919.10P

    Patients

    Seq Age Sex Outcome Treatment
    1 YR