FDA Adverse Event
Malfunction
Summary report: N
GENERAL ELECTRIC MEDICAL SYSTEM
MDR report key: 90262
·
Received May 7, 1997
Report
- Report Number
- 90262
- Event Type
- Malfunction
- Date Received
- May 7, 1997
- Date of Event
- October 5, 1994
- Report Date
- March 26, 1997
- Manufacturer
- G. E. MEDICAL SYSTEMS
- Product Code
- IYX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT SUSTAINED CONTUSION TO CHEST, (XYPHOID AREA), DURING A NUCLEAR IMAGE PROCEDURE. NO THYROID PROBLEMS UPON EXAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENERAL ELECTRIC MEDICAL SYSTEM | GAMMA CAMERA | IYX | G. E. MEDICAL SYSTEMS | 46-300130G2 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |