ISOLITE PEDIATRIC MOUTHPIECE
Received Jan 21, 2015 · Event occurred Jan 8, 2015
Report 2032574-2015-00001 · MDR key 4479309
Device
Product problems
- Use of Device Problem
Patient
3 YR
- Aspiration/Inhalation
Narrative
Description of Event or Problem
ON (B)(6) 2015, THE DOCTOR WAS WORKING ON A (B)(6) PATIENT UNDER UNCONSCIOUS I.V. SEDATION TO FIX FILLINGS AND PERFORM A ROOT CANAL. THE DOCTOR WAS USING AN ISOLITE PEDIATRIC SIZE MOUTHPIECE AND HAD PACKED THE PATIENTS THROAT WITH COTTON AS PER STANDARD DENTAL PROTOCOL. THE PATIENT CHAIR WAS IN A FULLY RECLINED POSITION. APPROXIMATELY 10-15 MINUTES FROM THE START OF THE PROCEDURE THE NURSE ANESTHETIST NOTICED THAT THE PATIENT WAS BEGINNING TO TURN BLUE AND THE PULSE OX MONITOR WAS DROPPING. SHE IMMEDIATELY ALERTED THE DOCTOR AND THEY REMOVED THE MOUTHPIECE AND THROAT PACK. THE PATIENTS COLOR AND PULSE RETURNED TO NORMAL AND THEY CONTINUED THE PROCEDURE USING A RUBBER DAM WITH NO FURTHER COMPLICATIONS.