ACID ETCH TOOTH CONDITIONER GEL
Received Jan 29, 1996 · Event occurred Nov 10, 1995
Report MW1008216 · MDR key 29573
Device
Product problems
- Material Separation
- Tip breakage
Patient
65 YR
- Surgical procedure
Narrative
Description of Event or Problem
THE GEL IS CONTAINED IN SYRINGE SYSTEM WITH A REPLACEABLE STERILE TIP. AS THE DENTIST WAS INSERTING THE CONDITIONER, THE TIP SEPARATED AND FELL INTO THE PT'S MOUTH. PT WENT TO THE ER AND REQUIRED A BRONCHOSCOPY TO RETRIEVE THE TIP.