MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-26 for NUCLEAR MEDICINE CAMERA MELLENIUM MG manufactured by Ge.
Report Number | MW5091331 |
MDR Report Key | 9383966 |
Date Received | 2019-11-26 |
Date of Report | 2019-11-25 |
Date of Event | 2019-11-14 |
Date Added to Maude | 2019-11-27 |
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 |
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 | NUCLEAR MEDICINE CAMERA |
Generic Name | SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION |
Product Code | KPS |
Date Received | 2019-11-26 |
Model Number | MELLENIUM MG |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | GE |
Manufacturer Address | NORWICH NY 13815 US 13815 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-26 |