BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE DIAMETER LACRIMAL INTUBATION SET/STENTUBE

    MDR report key: 790456 · Received November 22, 2006

    Report

    Report Number
    1649914-2006-00114
    Event Type
    Malfunction
    Date Received
    November 22, 2006
    Date of Event
    September 26, 2006
    Report Date
    November 22, 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 THE TUBES BROKE DURING A PROCEDURE. ANOTHER SET WAS USED TO FINISH THE CASE. THE SAMPLE WAS SAVED AND WILL BE RETURNED TO QUEST. PRODUCT CODE LIS052; LOT NUMBER 24392.10X. (KIT CODE DCR904-BI).

    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 24392.10X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN