MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for STA COMPACT 58612 manufactured by Diagnostica Stago.
| Report Number | 2245451-2020-00002 |
| MDR Report Key | 9610237 |
| Date Received | 2020-01-21 |
| Date of Report | 2019-12-03 |
| Date of Event | 2019-12-02 |
| Date Facility Aware | 2019-12-03 |
| Report Date | 2020-01-20 |
| Date Reported to FDA | 2020-01-20 |
| Date Reported to Mfgr | 2020-01-20 |
| Date Added to Maude | 2020-01-21 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Brand Name | STA COMPACT |
| Generic Name | IVD COAGULATION DEVICE / INSTRUMENT, PRODUCT CODE: JPA |
| Product Code | JPA |
| Date Received | 2020-01-21 |
| Model Number | 58612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO |
| Manufacturer Address | 3 ALL?E TH?R?SA ASNI?RES-SUR-SEINE, 92600 FR 92600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-21 |