FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1341859
·
Received March 11, 2009
Report
- Report Number
- 2183553-2009-00015
- Event Type
- Injury
- Date Received
- March 11, 2009
- Date of Event
- March 28, 2008
- Report Date
- February 10, 2009
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- LNH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
A PATIENT REPORTEDLY RECEIVED UNNECESSARY SURGERY BECAUSE THE WRONG PROTOCOL WAS USED WHEN PERFORMING AN MR EXAM. ACCORDING TO THE GE HEALTHCARE FIELD ENGINEER, THE DOCTOR AND SITE ADMINISTRATION AGREED THE EVENT WAS NOT CAUSED BY THE MR SYSTEM. THE TECHNICIAN HAD ENTERED THE WRONG PROTOCOL. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE INCIDENT FROM THE SITE. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | LNH | GE MEDICAL SYSTEMS, LLC | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |