FDA Adverse Event
Malfunction
Summary report: N
BENCO 30G SHORT PLASTIC HUB NEEDLE
MDR report key: 509910
·
Received January 13, 2004
Report
- Report Number
- 1412902-2004-00007
- Event Type
- Malfunction
- Date Received
- January 13, 2004
- Report Date
- December 8, 2003
- Manufacturer
- DENTSPLY MPL
- Product Code
- DZA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
THE DOCTOR REPORTED THAT A NEEDLE BROKE OFF IN THE PT'S MOUTH. THE PT WAS REFERRED TO AN ORAL SURGEON FOR SURGICAL REMOVAL OF THE NEEDLE. THE ORAL SURGEON ELECTED TO NOT REMOVE THE NEEDLE AT THIS TIME DUE TO THE LOCATION NEAR A NERVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BENCO 30G SHORT PLASTIC HUB NEEDLE | DENTAL NEEDLE | DZA | DENTSPLY MPL | NA | 8876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Other |