FDA Adverse Event
Injury
Summary report: N
GE INSIGT 1.5 TESLA
MDR report key: 3961133
·
Received July 23, 2014
Report
- Report Number
- MW5037438
- Event Type
- Injury
- Date Received
- July 23, 2014
- Date of Event
- July 10, 2014
- Report Date
- July 22, 2014
- Manufacturer
- SUTTER HEALTH GE
- Product Code
- LNH
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD A NON CONTRAST MRI OF MY HIPS. I SUFFERED A SEVERE 2ND DEGREE BURN ON MY LEFT ELBOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 432090 | GE INSIGT 1.5 TESLA | MRI SYSTEM | LNH | SUTTER HEALTH GE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |