FDA Adverse Event
Injury
Summary report: N
PREMIER BIG EASY ULTRALITE GRACEY 11/12
MDR report key: 793382
·
Received December 12, 2006
Report
- Report Number
- 2511556-2006-00001
- Event Type
- Injury
- Date Received
- December 12, 2006
- Date of Event
- November 9, 2006
- Report Date
- November 9, 2006
- Manufacturer
- PREMIER DENTAL PRODUCTS CO.
- Product Code
- ELA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREMIER BIG EASY ULTRALITE GRACEY 11/12 | ELA | ELA | PREMIER DENTAL PRODUCTS CO. | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |