MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-08 for GENERAL ELECTRIC MR 750W manufactured by General Electric Magnetic Resonance.
[3393268]
Pt underwent mri on (b)(6) 2013. On (b)(6) 2013, i was notified that pt is reporting continuing tinnitus and ear pain since his mri.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029731 |
| MDR Report Key | 3057329 |
| Date Received | 2013-04-08 |
| Date of Report | 2013-04-08 |
| Date of Event | 2013-02-19 |
| Date Added to Maude | 2013-04-16 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENERAL ELECTRIC MR 750W |
| Generic Name | MRI |
| Product Code | ORR |
| Date Received | 2013-04-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENERAL ELECTRIC MAGNETIC RESONANCE |
| Manufacturer Address | 3200 N. GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-08 |