FDA Adverse Event
Other
Summary report: N
INTERA 1.5
MDR report key: 1625938
·
Received March 1, 2010
Report
- Report Number
- 3003768277-2010-00037
- Event Type
- Other
- Date Received
- March 1, 2010
- Date of Event
- February 17, 2010
- Report Date
- February 22, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- LNH
- PMA / PMN Number
- K001796
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MFR IN (B)(6), TO SUBMIT THIS EVENT THAT HAPPENED IN (B)(6). PROBLEM: PT WAS SCANNED WITH A CARDIAC COIL ON THIS MR SYSTEM. IMMEDIATELY AFTER THE EXAMINATION, A SECOND DEGREE BURN WITH A 5 CM BLISTER WAS FOUND ON THE PT'S RIGHT LOWER ABDOMEN. THE COIL CABLE TOUCHED THE PT'S SKIN AT THE LOCATION OF THE BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERA 1.5 | LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) | LNH | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | 781106 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other |