BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLADSTONE-PUTTERMAN

    MDR report key: 1571190 · Received December 23, 2009

    Report

    Report Number
    1571190
    Event Type
    Malfunction
    Date Received
    December 23, 2009
    Date of Event
    November 3, 2009
    Report Date
    December 23, 2009
    Manufacturer
    GUNTHER WEISS SCIENTIFIC GLASSBLOWING CO., INC
    Product Code
    HNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE INSERTING A NEW GLADSTONE PUTTERMAN TUBE IN THE PATIENT'S RIGHT EYE, THE END OF THE TUBE BROKE. PHYSICIAN SEARCHED ENTIRE OPERATIVE FIELD FOR BROKEN PART. UNABLE TO LOCATE IT AND BELIEVES THAT IT MAY HAVE BEEN SUCTIONED UP. THE BROKEN PART MEASURED 0.5 X 1 MM IN SIZE. A NEW TUBE WAS PLACED WITHOUT INCIDENT. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLADSTONE-PUTTERMAN LACRIMAL TUBE HNW GUNTHER WEISS SCIENTIFIC GLASSBLOWING CO., INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR