MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-03 for GE MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM 5462139 manufactured by Ge Medical Systems Scs.
| Report Number | MW5090226 |
| MDR Report Key | 9156644 |
| Date Received | 2019-10-03 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-09-20 |
| Date Added to Maude | 2019-10-04 |
| 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 | 0 |
| Brand Name | GE MAMMOGRAPHIC TOMOSYNTHESIS SYSTEM |
| Generic Name | DIGITAL BREAST TOMOSYNTHESIS |
| Product Code | OTE |
| Date Received | 2019-10-03 |
| Model Number | 5462139 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS SCS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-10-03 |