MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-14 for EMAG? INSTRUMENT 418591 manufactured by Biomerieux Italia S.p.a..
| Report Number | 9615037-2019-00014 |
| MDR Report Key | 8893576 |
| Date Received | 2019-08-14 |
| Date of Report | 2019-11-07 |
| Date Mfgr Received | 2019-10-10 |
| Date Added to Maude | 2019-08-14 |
| 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 | MS. JENNIFER ARMSTRONG |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145068201 |
| Manufacturer G1 | BIOMERIEUX ITALIA S.P.A. |
| Manufacturer Street | VIA DI CAMPIGLIANO 58 / LOC. P 50012 BAGNO A RIPOLI |
| Manufacturer City | FIRENZE, |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMAG? INSTRUMENT |
| Generic Name | EMAG? INSTRUMENT |
| Product Code | JJH |
| Date Received | 2019-08-14 |
| Model Number | 418591 |
| 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 ITALIA S.P.A. |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 / LOC. P 50012 BAGNO A RIPOLI FIRENZE, IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-14 |