Description of Event or Problem · 1
THE FOLLOWING STATEMENT WAS DOCUMENTED IN MEDENNIUM'S CONTACT US CONTROLLED FORM, UNDER THE PRODUCT EXPERIENCE REPORT SECTION, BY THE PATIENT AND SEVERAL PHYSICIANS. PATIENT REPORTED IN 2007 THAT SHE WAS SCHEDULED FOR SURGERY IN ORDER TO REMOVE THE PLUGS THAT HAD BEEN BOTHERING HER FOR ABOUT 6 WEEKS, BUT SHE DID NOT WANT TO HAVE SURGERY. A DR. HAD ATTEMPTED IRRIGATION A WEEK BEFORE WITHOUT SUCCESS AND SHE HAD BEEN ON SEVERAL OINTMENTS AND DROPS WITHOUT SUCCESS. SHE WAS LAST ON VIGAMOX AND WARM COMPRESSES IN ORDER TO PREPARE HER FOR SURGERY. THE PLUGS HAD BEEN PLACED IN THE LOWER PUNCTA BACK IN 2004. MEDENNIUM SENT THE PT TO SEE ANOTHER DR WHO CULTURED THE AREA AND PRESCRIBED ORAL ANTIBIOTIC LEVAQUIN. THE CULTURE REPORTS WERE AVAILABLE ON 02-22-2007 AND SHOWED THE PRESENCE OF I CANELLA, A BACTERIA COMMONLY SEEN IN THE MOUTH. UPON FURTHER DISCUSSION, THE PATIENT REPORTED THAT SHE HAD A RECENT ROOT CANAL WITH COMPLICATIONS. THE DR SUSPECTED A POSSIBLE SINUSITIS OF THE INFERIOR TURBINATES AND RECOMMENDED A CT SCAN WHICH CAME OUT NORMAL, AND THE DR ALSO REPORTED THAT THE PATIENT WAS SHOWING LESS DISCHARGE AND BLEEDING WITH ORAL AMOXICILLIN. THE DR CONTACTED THE DENTIST WHO PERFORMED X-RAYS OF THE ROOT CANAL AND FOUND THE AREA FREE OF INFECTION. ON 03/05/2007, THE DR REPORTED THAT THE PATIENT WAS DOING BETTER ON THE ORAL AMOXICILLIN, AND THEN HE SENT THE PATIENT TO AN OCULOPLASTIC FOR IRRIGATION. FOUR DAYS LATER, THE PATIENT REPORTED THAT THE OCULOPLASTIC WAS ABLE TO IRRIGATE THROUGH THE PUNCTUM AND HAD PUT HER ON A DROP CALLED ZYLET. SHE WAS ALSO TOLD THAT SHE MAY HAVE LACRIMAL STONES AND THAT EXPLAINED THE BLEEDING THAT HAD BEEN SEEN IN THE PAST. THE LAST COMMUNICATION WE HAD WITH THE PATIENT WAS THE FOLLOWING MONTH. SHE REPORTED SEEN THE OCULOPLASTIC APPROX ONE MONTH EARLIER, WHO TOLD HER THAT THE SITUATION HAD RESOLVED. SMARTPLUG HAS BEEN REMOVED AND NO LONGER POSES A RISK TO THE PATIENT. CASE IS CLOSED. NO ADDITIONAL INFORMATION CAN BE EXPECTED.