FDA Adverse Event
Injury
Summary report: N
MAGNETOM AERA
MDR report key: 4905286
·
Received July 6, 2015
Report
- Report Number
- 2240869-2015-13862
- Event Type
- Injury
- Date Received
- July 6, 2015
- Date of Event
- May 11, 2015
- Report Date
- June 4, 2015
- Manufacturer
- SIEMENS GMBH
- Product Code
- LNH
- PMA / PMN Number
- K133435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SIEMENS HAS REQUESTED ADDITIONAL INFORMATION TO PROCEED WITH INVESTIGATION OF THE REPORTED INCIDENT.
Additional Manufacturer Narrative · 1
DESPITE REPEATED REQUESTS FOR MORE INFORMATION REGARDING THE REPORTED INCIDENT AND THE INJURY TO THE PATIENT, NO DATA WAS PROVIDED. THEREFORE, AN ANALYSIS OF THIS INCIDENT WAS NOT POSSIBLE. THE ROOT CAUSE OF THE DESCRIBED BURNING COULD NOT BE DETERMINED DUE TO MISSING DATA.
Description of Event or Problem · 1
IT WAS REPORTED TO SIEMENS THAT A PATIENT RECEIVED BURNS WHILE UNDERGOING AN EXAMINATION ON THE MAGNETOM AERA UNIT. THE PATIENT RECEIVED A PLASTIC SURGERY AFTER THE INCIDENT. NO OTHER INFORMATION WAS PROVIDED TO SIEMENS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436678 | MAGNETOM AERA | LNH | SIEMENS GMBH | 10432914 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |