MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-25 for OMRON BLOOD PRESSURE MONITOR, BP786N HEM-7321T-Z(V) manufactured by Omron Healthcare, Inc..
| Report Number | MW5090040 |
| MDR Report Key | 9123900 |
| Date Received | 2019-09-25 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-09-24 |
| Date Added to Maude | 2019-09-26 |
| 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 | PATIENT |
| 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 | OMRON BLOOD PRESSURE MONITOR, BP786N |
| Generic Name | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
| Product Code | DXN |
| Date Received | 2019-09-25 |
| Model Number | BP786N |
| Catalog Number | HEM-7321T-Z(V) |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRON HEALTHCARE, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-25 |