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 2019-07-25 for CHROMID? CPS ELITE OPAQUE AGAR 418206 manufactured by Biomerieux Espa?a.
| Report Number | 3009307598-2019-00002 |
| MDR Report Key | 8826235 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-07-25 |
| Date of Report | 2019-08-26 |
| Date Mfgr Received | 2019-08-01 |
| Device Manufacturer Date | 2019-03-26 |
| Date Added to Maude | 2019-07-25 |
| 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. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX ESPA |
| Manufacturer Street | ISAAC NEWTON, 6 TRES CANTOS |
| Manufacturer City | MADRID, 28760 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 28760 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? CPS ELITE OPAQUE AGAR |
| Generic Name | CHROMID? CPS ELITE OPAQUE AGAR |
| Product Code | JXA |
| Date Received | 2019-07-25 |
| Catalog Number | 418206 |
| Lot Number | 1007230410 |
| Device Expiration Date | 2019-07-22 |
| 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 ESPA?A |
| Manufacturer Address | ISAAC NEWTON, 6 TRES CANTOS MADRID, 28760 SP 28760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-25 |