MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-30 for SIEMENS SYMPHONY 1.5 NA manufactured by Siemens.
[27459749]
Patient's left breast became hot during scanning. Physician noted red area approx 70 cm. Type of mri scan was noncontrast cervical and lumbar spine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5124638 |
| MDR Report Key | 5124638 |
| Date Received | 2004-07-30 |
| Date of Report | 2004-07-14 |
| Date of Event | 2004-07-08 |
| Date Facility Aware | 2004-07-08 |
| Report Date | 2004-07-14 |
| Date Reported to Mfgr | 2004-07-14 |
| Date Added to Maude | 2015-10-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 0 |
| Brand Name | SIEMENS SYMPHONY 1.5 |
| Generic Name | MRI |
| Product Code | MRI |
| Date Received | 2004-07-30 |
| Model Number | SYMPHONY 1.5 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS |
| Manufacturer Address | INDEPENDENCE OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-07-30 |