D
Patient 1
IT WAS REPORTED THAT THE TIP OF A MINIATURE PIN AND LIGATURE CUTTER SEPARATED OUTSIDE OF A PATIENT'S MOUTH; THERE WAS NO INDICATION THAT INJURY RESULTED.
MAUDE MDR 1813379
- MDR report key
- 1813379
- Report number
- 2086211-2010-00120
- Event key
- 0
- Event type
- 3
- Date received
- 2010-08-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- HELEN LEWIS
- Address
- 221 W. PHILA. ST., STE. 60 SUSQUEHANNA COMMERCE CENTER W. YORK PA 17401 US
- Phone
- 717-717-7178
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MINIATURE PIN & LIGATURE CUTTER | GAC INTERNATIONAL | EJB | ODG1002 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-08-20 | 0 |
Event Narratives#
N
Patient 1
WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE WAS A PREVIOUS REPORT RECEIVED IN THE PAST TWO YEARS INVOLVING A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH IT HAS NOT BEEN RETURNED AS OF THIS REPORT.