FDA Adverse Event
Injury
Summary report: N
AMERICAN
MDR report key: 212204
·
Received March 1, 1999
Report
- Report Number
- 1412902-1999-00006
- Event Type
- Injury
- Date Received
- March 1, 1999
- Date of Event
- January 7, 1999
- Report Date
- February 26, 1999
- Manufacturer
- MPL TECHNOLOGIES
- Product Code
- DZM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
WHILE PERFORMING A MANDIBULAR BLOCK, THE NEEDLE BROKE OFF AT THE HUB. THE PT WAS REFERRED TO AN ORAL SURGEON. ON THE ADVICE OF THE ORAL SURGEON, THE NEEDLE REMAINED IN THE PT'S GUM TISSUE. THE PT IS ALSO SEEING AN EAR, NOSE, AND THROAT SPECIALIST. THERE HAS BEEN NO CHANGE IN THE PT'S ACTUAL MEDICAL STATUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMERICAN | DENTAL NEEDLE | DZM | MPL TECHNOLOGIES | 30G SHORT | 13022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |