MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for VIDAS? D-DIMER EXCLUSION II 30455-02 manufactured by Biomerieux Sa.
| Report Number | 8020790-2019-00026 |
| MDR Report Key | 8543815 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-06-08 |
| Date Mfgr Received | 2019-05-17 |
| Date Added to Maude | 2019-04-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIDAS? D-DIMER EXCLUSION II |
| Generic Name | VIDAS? D-DIMER EXCLUSION II |
| Product Code | DAP |
| Date Received | 2019-04-24 |
| Catalog Number | 30455-02 |
| Lot Number | 1006739790 |
| Device Expiration Date | 2019-08-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-24 |