FDA Adverse Event
Malfunction
Summary report: N
VITAL VUE X-LONG ORTH TIP W/EX METAL SUC
MDR report key: 1232076
·
Received November 7, 2008
Report
- Report Number
- 9610849-2008-00073
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 17, 2008
- Report Date
- November 4, 2008
- Manufacturer
- TIJUANA - USS
- Product Code
- GCX
- PMA / PMN Number
- K883201
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE PROCEDURE AND PATIENT DETAILS WERE NOT PROVIDED. THE PATIENT GOT BURNED BY THE DEVICE. THE DEGREE OF THE BURN IS UNKNOWN. NO PIECE FROM THE DEVICE FELL INTO THE PATIENT CAVITY, AND THERE WAS NO FURTHER DETAILS. THE PATIENT IS IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITAL VUE X-LONG ORTH TIP W/EX METAL SUC | SUCTION AND IRRIGATION DEVICE | GCX | TIJUANA - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |