FDA Adverse Event
Other
Summary report: N
PHASED ARRAY WRIST COIL
MDR report key: 556935
·
Received October 27, 2004
Report
- Report Number
- 556935
- Event Type
- Other
- Date Received
- October 27, 2004
- Date of Event
- October 26, 2004
- Report Date
- October 27, 2004
- Manufacturer
- IGC MEDICAL ADVANCES INC.
- Product Code
- MOS
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
PATIENT RECEIVED 1ST DEGREE BURNS (MILD SUNBURN-LIKE APPEARANCE) TO THE RIGHT WRIST, RIGHT HUMERUS AREA (UNDERARM) AND THE 2ND AND 3RD DIGITS OF THE RIGHT HAND DURING AN MRI STUDY. PATIENT WAS SWEATING DURING TESTING. THEY WERE ALSO MAKING CONTACT WITH THE MACHINE DURING SOME OF THE EXAMINATION. GE ENGINEER EXAMINED THE WRIST COILS OF THE MACHINE AND CHECKED CALIBRATION. NO PROBLEMS WERE FOUND APPLICABLE TO THE INJURY. SOME METAL SHAVINGS WERE FOUND IN THE COIL, BUT THIS WAS DETERMINED TO NOT BE APPLICABLE TO THE INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHASED ARRAY WRIST COIL | MRI EXTREMITY COIL | MOS | IGC MEDICAL ADVANCES INC. | 455GE-64 | NOT KNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | NO OTHER THERAPIES |