FDA Adverse Event
Injury
Summary report: N
VIVID-I WITH 6TC-RS TRANSDUCER
MDR report key: 2555831
·
Received April 27, 2012
Report
- Report Number
- 9610482-2012-00004
- Event Type
- Injury
- Date Received
- April 27, 2012
- Date of Event
- March 28, 2012
- Report Date
- March 28, 2012
- Manufacturer
- GE VINGMED ULTRASOUND AS
- Product Code
- IYN
- PMA / PMN Number
- K102388
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UNDER (B)(6) LAW, PT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT SUFFERED AN ESOPHAGEAL HEMATOMA FOLLOWING A TRANSOESOPHAGEAL ECHOCARDIOGRAM (TOE) UNDER ANESTHESIA USING A 6TC-RS TRANSDUCER. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIVID-I WITH 6TC-RS TRANSDUCER | ULTRASONIC IMAGING SYSTEM | IYN | GE VINGMED ULTRASOUND AS | KN100096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |