MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-09-30 for STA COMPACT MAX 58990 manufactured by Diagnostica Stago S.a.s.
| Report Number | 8043723-2019-00009 |
| MDR Report Key | 9134172 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-09-30 |
| Date of Report | 2019-08-13 |
| Date of Event | 2019-08-12 |
| Date Mfgr Received | 2019-08-13 |
| Device Manufacturer Date | 2014-01-22 |
| Date Added to Maude | 2019-09-30 |
| 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 |
| 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, 95240 |
| Manufacturer Country | FR |
| Manufacturer Postal | 95240 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STA COMPACT MAX |
| Generic Name | IVD COAGULATION DEVICE/INSTRUMENT |
| Product Code | JPA |
| Date Received | 2019-09-30 |
| Model Number | 58990 |
| Device Availability | Y |
| 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 TH?R?SA ASNI?RES SUR SEINE, 92600 FR 92600 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-30 |