SCOTCHBOND UNIVERSAL ETCHANT

Description of Event or Problem

(B)(6) PATIENT EXPERIENCED A BURN IN THE EYE AFTER AN INCIDENTAL EXPOSURE TO 3M (TM) ESPE (TM) SCOTCHBOND (TM) UNIVERSAL ETCHANT. DENTAL OFFICE REPORTED THEY TESTED THE SUBJECT PRODUCT BEFORE THE PROCEDURE AND IT WAS WORKING PROPERLY; HOWEVER, THE SYRINGE TIP CAME OFF AND ETCHANT SPILLED IN PATIENT'S EYE. THE DENTAL PROFESSIONALS IMMEDIATELY FLUSHED THE EYE, AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR FURTHER TREATMENT. THE PATIENT RECEIVED ANOTHER EYE FLUSH AT THE ER AND WAS PRESCRIBED EYE SALVE TO BE APPLIED EVERY 2 HOURS. THE PATIENT WAS SEEN AT THE HOSPITAL FOR FOLLOW-UP THE FOLLOWING DAY ((B)(6)) WHERE IT WAS RECOMMENDED THAT SALVE BE APPLIED EVERY HOUR AND TO RETURN ON (B)(6) FOR ANOTHER EVALUATION. THE MOTHER OF THE PATIENT REPORTED THAT THE DIAGNOSIS IS A BURN IN THE EYE. THE DENTAL OFFICE HAS MADE SEVERAL ATTEMPTS TO FOLLOW-UP FOR CURRENT PATIENT STATUS; NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.

Additional Manufacturer Narrative

IT REMAINS UNCLEAR HOW THE TIP OF THE SYRINGE CAME OFF ALLOWING ETCHANT TO SPILL IN THE PATIENT'S EYE; DENTAL OFFICE IS UNWILLING, AT THIS TIME, TO RETURN THE COMPLAINT SAMPLE FOR EVALUATION BY 3M ESPE. THE GLOBAL CLINICAL COMPLAINT HISTORY FOR THE SUBJECT PRODUCT IS FAVORABLE. THERE HAVE BEEN NO OTHER COMPLAINTS OF THIS NATURE REPORTED, INCLUDING NO REPORTS OF THE ETCHANT SYRINGE TIP COMING OFF BEFORE OR DURING USE.