FDA Adverse Event
Malfunction
Summary report: N
BITE-GARD MOLAR BITE BLOCK
MDR report key: 1204669
·
Received October 20, 2008
Report
- Report Number
- 3004365956-2008-00057
- Event Type
- Malfunction
- Date Received
- October 20, 2008
- Report Date
- October 3, 2008
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- JXL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SAMPLE REQUESTED BUT NOT RECEIVED YET. EVALUATION REPORT NOT AVAILABLE AT TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT WAS REPORTED AS: HEALTH CARE PROVIDER WAS ATTENDING TO ROUTINE MOUTH CARE WHEN IT WAS NOTICED THAT THE PT'S BITE-GARD WAS NO LONGER SITTING IN THE RIGHT PLACE. IN AN ATTEMPT TO REPOSITION IT, THE HANDLE DISCONNECTED FROM THE GREEN PLASTIC END. NO PT INJURY REPORTED. NO FURTHER INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BITE-GARD MOLAR BITE BLOCK | BITE GARD | JXL | TELEFLEX MEDICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |