FDA Adverse Event
Injury
Summary report: N
GE 750W
MDR report key: 19998708
·
Received August 15, 2024
Report
- Report Number
- MW5158535
- Event Type
- Injury
- Date Received
- August 15, 2024
- Date of Event
- July 30, 2024
- Report Date
- August 13, 2024
- Manufacturer
- GE HEALTHCARE MANUFACTURING LLC.
- Product Code
- LNH
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PAIN TO SCALP AND LEFT BROW AFTER MRI ON (B)(6) 2024, HOWEVER, NEXT DAY PATIENT CALLED BACK TO TELL US THEY DEVELOPED SHINGLES OUTBREAK IN THE SAME LOCATION SHE WAS FEELING PAIN. IT IS NOW FELT THERE IS NO REPORTABLE CONDITION RELATED TO THIS EQUIPMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1620005 | GE 750W | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING | LNH | GE HEALTHCARE MANUFACTURING LLC. | 719255MR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Other |