DARBY TEMPORARY CEMENT SOLUTION

Additional Manufacturer Narrative

ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. EYE CONTACT IS ADDRESSED IN THE DIRECTIONS FOR USE. THE DIRECTIONS STATE, "CONCENTRATED DETERGENT MIXTURE CONTAINS SODIUM HYDROXIDE. MAY CAUSE SKIN OR EYE IRRITATION. HARMFUL IF SWALLOWED. IN CASE OF CONTACT, FLUSH EYES OR SKIN WITH PLENTY OF WATER. IF IRRITATION PERSISTS, SEEK MEDICAL ATTENTION." NO FAILURE OF THE MEDICAL DEVICE WAS DETECTED. EYE IRRITATION IS A KNOWN INHERENT RISK OF USING THIS MEDICAL DEVICE, AND USER ERROR IN FAILING TO USE ADEQUATE EYE PROTECTION CONTRIBUTED TO THIS EVENT. PRODUCT WAS NOT RETURNED.

Description of Event or Problem

BY WAY OF (B)(6), MALE DARBY DENTAL REP CALLED FROM (B)(6), ASKING FOR SDS OF DARBY TEMPORARY CEMENT SOLUTION. HE WAS CALLING ON BEHALF OF A CUSTOMER WHO HAD SPLASHED IT IN HER EYE. SHE WAS ENROUTE TO HOSPITAL AND WANTED THE INFORMATION ON HER PHONE WHEN SHE ARRIVED. I FORWARDED THE SDS TO (B)(4). NO FURTHER DETAILS WERE PROVIDED. THIS IS A SERIOUS INJURY (AS DEFINED IN 21 CFR SECTION 803.3) AND REQUIRES INTERVENTION TO PREVENT POTENTIAL PERMANENT HARM TO A BODY STRUCTURE. THIS INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION.