MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for BLOOD PRESSURE MACHINE manufactured by Unk.
| Report Number | MW5090104 |
| MDR Report Key | 9134827 |
| Date Received | 2019-09-27 |
| Date of Report | 2019-09-20 |
| Date Added to Maude | 2019-09-30 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLOOD PRESSURE MACHINE |
| Generic Name | SYSTEM, MEASUREMENT, BLOOD PRESSURE, NONINVASIVE |
| Product Code | DXN |
| Date Received | 2019-09-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | LARGE CUFF |
| Generic Name | BLOOD PRESSURE CUFF |
| Product Code | DXN |
| Date Received | 2019-09-27 |
| Device Availability | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | SMALL CUFF |
| Generic Name | BLOOD PRESSURE CUFF |
| Product Code | DXN |
| Date Received | 2019-09-27 |
| Device Availability | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-27 |