FDA Adverse Event
Injury
Summary report: N
INTERA 1.5T MASTER/NOVA
MDR report key: 2230721
·
Received August 17, 2011
Report
- Report Number
- 3003768277-2011-00479
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- June 15, 2011
- Report Date
- July 28, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- LNH
- PMA / PMN Number
- K001796
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). (EVAL 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.
Description of Event or Problem · 1
THE PT WAS SCANNED WITH THE SENSE CARDIAC COIL IN A SUPINE, HEAD FIRST POSITION. AFTER THE EXAMINATION A BURN WAS FOUND ON HIS LOWER ABDOMEN, WITH A SIZE OF 2X5 CM. THE SIZE OF THE 2ND DEGREE BLISTER WAS APPROX 2X1 CM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERA 1.5T MASTER/NOVA | LNH | PHILIPS HEALTHCARE | 781106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |