FDA Adverse Event
Injury
Summary report: N
INTERA 1.5T
MDR report key: 1912370
·
Received November 23, 2010
Report
- Report Number
- 3003768277-2010-00315
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- October 21, 2010
- Report Date
- November 16, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- LNH
- PMA / PMN Number
- K001987
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(METHOD, RESULTS, CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA. (B)(4).
Description of Event or Problem · 1
THIS PATIENT HAD AN MR PROCEDURE. THE PATIENT WAS SCANNED IN HEAD FIRST, SUPINE POSITION WITH THE SENSE SPINAL COIL. A FEW HOURS AFTER THE EXAMINATION, SECOND DEGREE BURNS WERE FOUND ON THE THUMB AND UPPER EXTREMITIES OF THE PATIENT AT THEIR POINT OF CONTACT. THE SIZE OF THE SECOND DEGREE BURNS WERE APPROX 1.5CM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERA 1.5T | LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) | LNH | PHILIPS MEDICAL SYSTEMS | 781195 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |