FDA Adverse Event
Injury
Summary report: N
ACS-NT
MDR report key: 1823396
·
Received August 24, 2010
Report
- Report Number
- 3003768277-2010-00169
- Event Type
- Injury
- Date Received
- August 24, 2010
- Date of Event
- July 26, 2010
- Report Date
- August 11, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- LNH
- PMA / PMN Number
- K945945
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL RESULTLS AND CONCLUSION: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE PATIENT HAD AN MR EXAM. SHE WAS SCANNED WITH THE SENSE HEAD COIL FOR A FOOT EXAMINATION. SHE HAD AN ALUMINUM SPLINT AROUND THE FOOT AND AFTER THE EXAMINATION, A SECOND DEGREE BURN (SIZE UNKNOWN) WAS FOUND ON THIS FOOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACS-NT | LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) | LNH | PHILIPS MEDICAL SYSTEMS | 78107 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 YR | Other |