PALODENT

Description of Event or Problem

DOCTOR REPORTED A MALFUNCTION OF RING PLACEMENT FORCEPS CAUSED RING TO FALL INTO PATIENT'S MOUTH. PATIENT DID NOT SWALLOW RING AND THERE IS NO REPORT OF INJURY.

Additional Manufacturer Narrative

WHILE THERE WAS NO INJURY REPORTED IN THIS CASE, A PREVIOUS REPORT WAS FILED PERTAINING TO IRREVERSIBLE DAMAGE TO A TOOTH REQUIRING INTERVENTION, THEREBY ESTABLISHING THAT THE MALFUNCTION IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. THEREFORE, THIS EVENT IS REPORTABLE. FURTHER TESTING WILL BE PERFORMED ON THE RETURNED DEVICE AND RESULTS WILL BE REPORTED AS THEY BECOME AVAILABLE. RESULTS OF THE DHR REVIEW ARE ATTACHED.