COMFORT PLUS PREMIUM SALIVA EJECTORS
Received Sep 14, 2020 · Event occurred Aug 18, 2020
Report 2433773-2020-00004 · MDR key 10532477
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE USER FACILITY REPORTED A SALIVA EJECTOR TIP DETACHED FROM THE COMFORT PLUS PREMIUM SALIVA EJECTOR TUBE DURING A DENTAL PROCEDURE. THE TIP WAS NOT SWALLOWED BY THE PATIENT. THE PATIENT WAS UNDER LOCAL ANESTHETIC DURING THE PROCEDURE WHEN THE SALIVA EJECTOR TIP WAS DETACHED. IT WAS REPORTED THE DENTIST PERFORMING THE PROCEDURE WAS ABLE TO RETRIEVE THE SALIVA EJECTOR TIP FROM THE PATIENTS MOUTH BEFORE IT WAS SWALLOWED. THE REPORTED EVENT DID NOT CAUSE OR CONTRIBUTE ANY SERIOUS INJURY OR DETERIORATION OF HEALTH. THIS EVENT COULD POTENTIALLY LEAD TO SERIOUS INJURY IF IT WERE TO RECUR. THIS COMPLAINT WILL BE MONITORED IN THE CROSSTEX COMPLAINT HANDLING SYSTEM.
Description of Event or Problem
THE USER FACILITY REPORTED A SALIVA EJECTOR TIP DETACHED FROM THE COMFORT PLUS PREMIUM SALIVA EJECTOR TUBE DURING A DENTAL PROCEDURE. THE TIP WAS NOT SWALLOWED BY THE PATIENT.