InjuryELA

PREMIER BIG EASY ULTRALITE GRACEY 11/12

Received Dec 12, 2006 · Event occurred Nov 9, 2006

Report 2511556-2006-00001 · MDR key 793382

Device

Generic name

Ela

Manufacturer

Premier Dental Products Co.

Model number

Catalog number

05611

Lot number

UNK

Product problems

Tip breakage
Device, removal of (non-implant)

Patient

Foreign body, removal of
Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

THE RDH WAS SCALING THE #18 TOOTH (2ND MOLAR) ON THE LINGUAL SIDE OF THE PATIENT'S MOUTH WITH A BIG EASY ULTRALITE GRACEY 11/12 CURETTE WHEN THE INSTRUMENT TIP BROKE AND THE PATIENT SWALLOWED THE TIP. THE PATIENT WENT TO THE EMERGENCY ROOM WHERE THE EMERGENCY ROOM DR USED AN ENDOSCOPE TO SUCCESSFULLY REMOVE THE 5-6MM PIECE FROM THE PATIENT'S STOMACH. THE OFFICE REPORTED THE PATIENT WAS DOING FINE IN A FOLLOW UP CONVERSATION. AS OF TODAY, PREMIER HAS BEEN UNABLE TO GET THE INSTRUMENT BACK FOR EVALUATION.