MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-19 for EMBOSPHERES MICROSPHERES S420GH S420GH/A manufactured by Merit Medical.
| Report Number | MW5088259 |
| MDR Report Key | 8811373 |
| Date Received | 2019-07-19 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-07-10 |
| Date Added to Maude | 2019-07-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | EMBOSPHERES MICROSPHERES |
| Generic Name | AGENTS, EMBOLIC, FOR TREATMENT OF BENIGN PROSTATIC HYPERPLASIA |
| Product Code | NOY |
| Date Received | 2019-07-19 |
| Model Number | S420GH |
| Catalog Number | S420GH/A |
| Lot Number | X1168511-5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2019-07-19 |