FDA Adverse Event
Other
Summary report: N
MODEL #800239
MDR report key: 761355
·
Received September 11, 2006
Report
- Report Number
- 2183683-2006-00001
- Event Type
- Other
- Date Received
- September 11, 2006
- Date of Event
- April 19, 2006
- Report Date
- September 6, 2006
- Manufacturer
- INVIVO CORPORATION
- Product Code
- MOS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, ANALYSIS OF INCIDENT AND POINTS TO MRI APPLICATION ERROR WHERE A LOOP WAS FORMED WITH PATIENT BODY LEADING TO SMALL RF BURN. NINETY SUBSEQUENT SCANS WITH PADDING WITH NO OTHER INCIDENTS SUPPORTS THIS. COIL IS BEING TESTED ADDITIONALLY BY MANF.
Description of Event or Problem · 1
MRI COIL, 800239. "TWO PATIENTS RECEIVED MILD SMALL RF BURN TO RIGHT THUMB AND BRUISE UNDER LEFT THUMB WITH SAME COIL. BURN WAS SMALL BLISTER, SMALLER THAN THE DIAMETER OF A PEA." SITE STARTED PADDING PATIENTS HANDS ON LATER SCANS AND HAS STATED THEY DID APPROX. 90 SCANS WITHOUT INCIDENT AFTERWARDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODEL #800239 | 7 CH BBC | MOS | INVIVO CORPORATION | 800239 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |