D
Patient 1
THE EVENT WAS REPORTED AS: DEVICE BROKE DURING USE. THE GREEN PART OF THE DEVICE WAS LEFT IN BACK OF PATIENT'S MOUTH WHEN IT BROKE. BROKEN PART RETRIEVED. NO PATIENT INJURY REPORTED.
MAUDE MDR 1722253
- MDR report key
- 1722253
- Report number
- 3004365956-2010-00071
- Event key
- 0
- Event type
- 3
- Date of event
- 2010-04-26
- Date received
- 2010-06-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- ANGELA BROWN, MANAGER
- Address
- P.O. BOX 12600 RTP NC 27709 US
- Phone
- 919-919-9194
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BITE-GARD MOLAR BITE BLOCK | BITE-GARD MOLAR BITE BLOCK | TELEFLEX MEDICAL | JXL | NA | 1140 | 02G0900707 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-06-02 | 0 |
Event Narratives#
N
Patient 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.