FDA Adverse Event
Malfunction
Summary report: N
BITE-GARD MOLAR BITE BLOCK
MDR report key: 1204671
·
Received October 20, 2008
Report
- Report Number
- 3004365956-2008-00059
- 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: BITE BLOCK WAS INSITU WHEN IT WAS REMOVED IT CAME APART AND THE GREEN ATTACHMENT LODGED IN THE PT'S THROAT, WHICH WAS REMOVED BY FORCEPS. NO REPORT OF PT INJURY. 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 |