inforMED
InjuryDYN

PREMIUM SALIVA EJECTOR

Received Mar 11, 2020 · Event occurred Feb 14, 2020

Report 2433773-2020-00002 · MDR key 9817427

Device

Generic name

Saliva Ejector

Model number

ZCB

Lot number

122719

Product problems

  • Break
  • Break

Patient

4 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

A DENTAL ASSISTANT REPORTED A SALIVA EJECTOR TIP DETACHED FROM THE SALIVA EJECTOR TUBE DURING A DENTAL PROCEDURE. THE TIP WAS SWALLOWED BY THE PATIENT. THE PATIENT WAS UNDER LOCAL ANESTHETIC DURING THE PROCEDURE WHEN THE SALIVA EJECTOR TIP WAS SWALLOWED. IT WAS REPORTED THE DENTIST PERFORMING THE PROCEDURE TRIED TO RETRIEVE THE SALIVA EJECTOR TIP FROM THE PATIENTS MOUTH BEFORE IT WAS SWALLOWED BUT THEY WERE UNSUCCESSFUL. THE PATIENT WAS TAKEN TO THE HOSPITAL, AN X-RAY WAS PERFORMED, AND THE SALIVA EJECTOR TIP WAS FOUND IN THE PATIENT'S STOMACH. THE RECOMMENDATION WAS TO HAVE THE PATIENT PASS THE SALIVA EJECTOR TIP THROUGH THEIR DIGESTIVE SYSTEM. THE PATIENT IS REPORTED TO BE DOING FINE. THERE IS NO REPORT AS TO IF THE SALIVA EJECTOR TIP PASSED THROUGH THE PATIENT'S DIGESTIVE SYSTEM. THIS COMPLAINT WILL BE MONITORED IN THE CROSSTEX COMPLAINT HANDLING SYSTEM.

Description of Event or Problem

A DENTAL ASSISTANT REPORTED A SALIVA EJECTOR TIP DETACHED FROM THE SALIVA EJECTOR TUBE DURING A DENTAL PROCEDURE. THE TIP WAS SWALLOWED BY THE PATIENT.

Remedial action

  • Patient Monitoring