FDA Adverse Event
Other
Summary report: N
INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL
MDR report key: 412854
·
Received August 23, 2002
Report
- Report Number
- 1529041-2002-00001
- Event Type
- Other
- Date Received
- August 23, 2002
- Date of Event
- March 1, 2002
- Report Date
- August 15, 2002
- Manufacturer
- USA INSTRUMENTS, INC.
- Product Code
- LNH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FROM DISTRIBUTOR REPORT: PATIENT SUFFERED 2ND DEGREE BURN TO THE ABDOMEN. FROM PHONE CONVERSATION WITH FIELD SERVICE ENGINEER: PATIENT LEFT HOPSITAL AFTER SCAN AND LATER COMPLAINED OF BURNING. PT CONSULTED THEIR OWN DOCTOR WHO SAID PT HAD A 2ND DEGREE BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL | MAGNETIC RESONANCE IMAGING ACCESSORY | LNH | USA INSTRUMENTS, INC. | INSIGHT PLUS 9000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Other |