BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI LITE

    MDR report key: 23730 · Received July 26, 1995

    Report

    Report Number
    23730
    Event Type
    Malfunction
    Date Received
    July 26, 1995
    Date of Event
    March 22, 1995
    Report Date
    March 22, 1995
    Manufacturer
    XINTEC CORP.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    QUARTZ J-TIP BROKE OFF DURING BLADDER NECK STRICUTRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI LITE 1000 MICRON FIBER WITH J-TIP GEX XINTEC CORP. EZ1010J 41002-01

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR