FDA Adverse Event
Injury
Summary report: N
SIGNA HDX 1.5T
MDR report key: 1313185
·
Received February 13, 2009
Report
- Report Number
- 2183553-2009-00008
- Event Type
- Injury
- Date Received
- February 13, 2009
- Date of Event
- September 30, 2008
- Report Date
- January 28, 2009
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- LNH
- PMA / PMN Number
- K052293
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
A PT REPORTEDLY SUSTAINED A QUARTER SIZE BLISTER ON HIS RIGHT FOREARM JUST BELOW HIS ELBOW DURING A SHOULDER COIL EXAM. THE PT WAS A LARGE PT WHO INADVERTENTLY WAS TOUCHING THE BORE AFTER THE PADDING HAD SHIFTED. THE PT WAS SEEN IN THE EMERGENCY ROOM AND HAS HAD FOLLOW UP PRIMARY CARE VISITS AND A NERVE STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGNA HDX 1.5T | LNH | GE MEDICAL SYSTEMS, LLC | 5110607 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |