MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for GE MRI MACHINE - ARTIST ARTIST 1.5 TESLA manufactured by General Electric Co..
[175053988]
This pt had an mri thoracic spine and afterwards she complained that her chest was itchy and red. No tests were required. The radiologist evaluated the pt and told her to take some oral benadryl for the itching. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092159 |
| MDR Report Key | 9580791 |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-09 |
| Date of Event | 2020-01-08 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE MRI MACHINE - ARTIST |
| Generic Name | SYSTM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-01-10 |
| Model Number | ARTIST 1.5 TESLA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENERAL ELECTRIC CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-10 |