MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-29 for FLEXLAB FLX manufactured by Inpeco Sa.
| Report Number | 3010825766-2019-00010 |
| MDR Report Key | 9391930 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-29 |
| Date of Report | 2019-11-29 |
| Date Mfgr Received | 2019-10-30 |
| Device Manufacturer Date | 2019-04-30 |
| Date Added to Maude | 2019-11-29 |
| 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 | MS EVA BALZAROTTI |
| Manufacturer Street | VIA TORRACCIA 26 |
| Manufacturer City | NOVAZZANO, 6883 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6883 |
| Manufacturer G1 | INPECO SPA |
| Manufacturer Street | VIA GIVOLETTO 15 |
| Manufacturer City | VAL DELLA TORRE, 10040 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 10040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXLAB |
| Generic Name | LABORATORY AUTOMATION SYSTEM |
| Product Code | CEM |
| Date Received | 2019-11-29 |
| Model Number | FLX |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INPECO SA |
| Manufacturer Address | VIA TORRACCIA 26 NOVAZZANO, 6883 SZ 6883 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-29 |