FDA Adverse Event
Injury
Summary report: N
GENERAL ELECTRIC
MDR report key: 19962299
·
Received August 9, 2024
Report
- Report Number
- MW5158304
- Event Type
- Injury
- Date Received
- August 9, 2024
- Date of Event
- July 30, 2024
- Report Date
- August 6, 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
HEATING TO SCALP AND LEFT EYEBROW AFTER MRI- PATIENT NOW HAS PAIN, SWELLING. PATIENT DID NOT HAVE ANY METALLIC IMPLANTS, JEWELRY OR SPRAY ON HAIR COLORING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2491906 | GENERAL ELECTRIC | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING | LNH | GE HEALTHCARE MANUFACTURING LLC | 750W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention |