BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRAWFORD LACRIMAL INTUBATION SET

    MDR report key: 121246 · Received September 15, 1997

    Report

    Report Number
    1926681-1997-00001
    Event Type
    Malfunction
    Date Received
    September 15, 1997
    Date of Event
    June 26, 1997
    Report Date
    July 31, 1997
    Manufacturer
    JEDMED INSTRUMENT CO.
    Product Code
    HMX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CRAWFORD SILICONE STENT WAS PASSED INTO LOWER CANALILUS. WHILE RETREIVING IT FROM THE NOSE, THE STENT SHEARED-OFF. THE SILICONE TUBING SHEARED OFF THE METAL PROBE, LEAVING A PIECE OF SILICONE WITHIN THE LACRIMAL. THIS NECESSITATED AN INCISION FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRAWFORD LACRIMAL INTUBATION SET * HMX JEDMED INSTRUMENT CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention