MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-27 for NUCLISENS? EXTRACTION BUFFER 3 280132 manufactured by Biomerieux, Sa.
| Report Number | 3008249922-2019-00004 |
| MDR Report Key | 9131067 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-09-27 |
| Date of Report | 2019-09-27 |
| Date Mfgr Received | 2019-08-30 |
| Device Manufacturer Date | 2019-02-15 |
| Date Added to Maude | 2019-09-27 |
| 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. MATTHEW LOCUS |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 5 RUE DES BERGES |
| Manufacturer City | 38024 GRENOBLE, |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLISENS? EXTRACTION BUFFER 3 |
| Generic Name | NUCL. EXTR. BUFFER 3(4X1L) |
| Product Code | LTD |
| Date Received | 2019-09-27 |
| Catalog Number | 280132 |
| Lot Number | Z010DD3EB |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, SA |
| Manufacturer Address | 5 RUE DES BERGES 38024 GRENOBLE, FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-27 |