FDA Adverse Event
Injury
Summary report: N
5.0/3.7 MHZ OMNI TEE TRANSDUCER
MDR report key: 509796
·
Received February 2, 2004
Report
- Report Number
- 3003723454-2004-00002
- Event Type
- Injury
- Date Received
- February 2, 2004
- Report Date
- January 28, 2004
- Manufacturer
- PHILIPS ULTRASOUND
- Product Code
- ITX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IRRITATED ESOPHAGEAL TISSUE, DISCOLORATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0/3.7 MHZ OMNI TEE TRANSDUCER | 21364A | ITX | PHILIPS ULTRASOUND | 21364A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| O |