BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERRICK LACRIMAL PLUG

    MDR report key: 268063 · Received March 8, 2000

    Report

    Report Number
    MW1018362
    Event Type
    Injury
    Date Received
    March 8, 2000
    Date of Event
    March 4, 1998
    Report Date
    March 1, 2000
    Manufacturer
    LACRIMEDICS, INC.
    Product Code
    HMX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EPIPHORA AFTER PLACEMENT OF HERRICK LACRIMAL PLUGS. PT COMPLAINS OF LEFT SIDED EPIPHORA AND RECURRING INFECTIONS. PT SAYS THAT PT HAD PLUGS PLACED IN TEAR DUCTS IN APPROX. 1997 AND HAS BEEN HAVING SOME DIFFICULTY SINCE THAT TIME. THE RIGHT SIDE IS NOT BOTHERING PT NEARLY AS MUCH AS THE LEFT SIDE DOES. PT COMPLAINS THAT THEY GET SWELLING OF EYELIDS, EXCESSIVE TEARING, AND IRRITATION OF EYES ALMOST EVERYDAY AND THAT THE LEFT SIDE IS CONSIDERABLY WORSE THAN THE RIGHT. ON EXAM PT DID HAVE SOME INCREASE IN TEAR FILM ON THE LEFT SIDE. DR TRIED TO IRRIGATE THE TEAR DUCTS. ON THE RIGHT SIDE, DR COULD GET FLUID TO PASS THROUGH THE SUPERIOR CANALICULUS INTO THE NOSE WITH SOME RESISTANCE. TRIED TO IRRIGATE THE RIGHT LOWER LID AND MOST OF THE FLUID CAME OUT THE RIGHT UPPER LID. ON THE LEFT SIDE, COULD NOT GET ANY FLUID TO PASS INTO THE NOSE THROUGH EITHER THE UPPER OR LOWER LID. DR DID PROBE THE CANALICULI ON THE LEFT AND DR COULD FEEL AN OBSTRUCTION AT THE COMMON CANALICULUS. NASAL ENDOSCOPY WAS PERFORMED AND IT APPEARED THAT THERE WAS ADEQUATE SPACE IN THE NOSE ON THE LEFT SIDE. COULD SEE CHANGES IN THE NOSE CONSISTENT WITH PREVIOUS SINUS INJURY AND PT MENTIONED THAT THEY HAVE HAD 2 SINUS OPERATIONS. PT HAS A LEFT COMMON CANALICULAR OBSTRUCTION FOLLOWING INSERTION OF A HERRICK PLUG. THIS IS CAUSING EXCESSIVE TEARING AND SOME RECURRING INFECTIONS. DR THINKS THE BEST APPROACH WOULD BE TO HAVE PT TRY THE TOBRADEX DROPS THAT PRIMARY DR ALREADY PRESCRIBED. IF THIS IS NOT HELPFUL, SURGERY COULD BE PERFORMED TO EXPLORE THE CANALICULI ON THE LACRIMAL SAC AND ATTEMPT REMOVAL OF THE HERRICK PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERRICK LACRIMAL PLUG LACRIMAL OCCLUSION DEVICE HMX LACRIMEDICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention