MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-14 for STA-R MAX 59010 manufactured by Diagnostica Stago S.a.s..
| Report Number | 8043273-2019-00005 |
| MDR Report Key | 8607618 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-14 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-03-06 |
| Date Facility Aware | 2019-04-17 |
| Report Date | 2019-05-13 |
| Date Reported to Mfgr | 2019-05-13 |
| Date Mfgr Received | 2019-04-25 |
| Device Manufacturer Date | 2016-11-09 |
| Date Added to Maude | 2019-05-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. WALID BEN AMMAR |
| Manufacturer Street | 2 RUE PIERRE FOSSATI |
| Manufacturer City | FRANCONVILLE VAL D'OISE, 95130 |
| Manufacturer Country | FR |
| Manufacturer Postal | 95130 |
| Manufacturer G1 | DIAGNOSTICA STAGO S.A.S. |
| Manufacturer Street | 3 ALL |
| Manufacturer City | ASNI |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STA-R MAX |
| Generic Name | IVD COAGULATION DEVICE/INSTRUMENT |
| Product Code | JPA |
| Date Received | 2019-05-14 |
| Model Number | 59010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO S.A.S. |
| Manufacturer Address | 3 ALL?E THERESA ASNI?RES-SUR-SEINE, 92600 FR 92600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-14 |