BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACRIMAL DUCT BALLOON CATHETER, 5MM

    MDR report key: 3126741 · Received May 20, 2013

    Report

    Report Number
    1649914-2013-00032
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 23, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    OKS
    PMA / PMN Number
    K935233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QUEST MEDICAL, INC. HAS LTD INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE PHYSICIAN WAS NOT ABLE TO INSERT THE CATHETER BALLOON INTO THE ADULT PT'S LACRIMAL DUCT. IT WAS REPORTED HE LUBRICATED THE BALLOON AND MADE A SECOND ATTEMPT BUT WAS UNSUCCESSFUL. F/U INFO WAS FOUND THAT AFTER THAT SECOND ATTEMPT THE PHYSICIAN DID NOT TRY USING ANOTHER CATHETER OR ONE OF ANOTHER SIZE DUE TO THE TRAUMA AND INFO TO THE PT'S EYE. THE CATHETER WAS RETURNED TO THE MFR FOR ANALYSIS. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222978 LACRIMAL DUCT BALLOON CATHETER, 5MM LACRIMAL DILATOR OKS QUEST MEDICAL, INC. DCR508UNI 043443

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention