inforMED
InjuryEKB

EXPLORER SE #23

Received Dec 1, 2004 · Event occurred Apr 1, 2004

Report 2411236-2004-12871 · MDR key 558149

Device

Generic name

Dental Instrument

Model number

*

Catalog number

100-3620

Lot number

0103

Product problems

  • Tip breakage

Patient

*

  • Foreign body, removal of
  • Therapy/non-surgical treatment, additional
  • Treatment with medication(s)
  • Hospitalization required

Narrative

Description of Event or Problem

IN 2004 FACILITY INC. RECEIVED NOTIFICATION VIA THE PATIENTS REPRESENTATIVE THAT THEIR CLIENT HAD SWALLOWED THE TIP OF AN EXPLORER THAT HAD BROKEN DURING A DENTAL EXAMINATION. THE TIP WAS LOCATED BY X-RAY IN THE ESOPHAGUS OF THE PATIENT, AND THE PATIENT WAS SUBSEQUENTLY ANESTHETIZED AND THE TIP REMOVED. THE PATIENT HAS RECOVERED WELL WITH NO AFTER EFFECTS.

Remedial action

  • Recall