MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-11-13 for REGENKIT-BCT RK-BCT-3 SF-26V321 manufactured by Regen Lab Sa.
| Report Number | 3008496303-2019-00001 |
| MDR Report Key | 9316561 |
| Report Source | FOREIGN |
| Date Received | 2019-11-13 |
| Date of Report | 2019-09-09 |
| Date of Event | 2019-09-03 |
| Date Mfgr Received | 2019-09-09 |
| Device Manufacturer Date | 2019-03-05 |
| Date Added to Maude | 2019-11-13 |
| 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 | JEAN-BAPTISTE PIGNIER |
| Manufacturer Street | EN BUDRON B2 |
| Manufacturer City | LE MONT-SUR-LAUSANNE, VAUD 1052 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 1052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REGENKIT-BCT |
| Generic Name | REGENKIT-BCT FAMILY KITS: PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2019-11-13 |
| Model Number | RK-BCT-3 |
| Catalog Number | SF-26V321 |
| Lot Number | 210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REGEN LAB SA |
| Manufacturer Address | EN BUDRON B2 LE MONT-SUR-LAUSANNE, VAUD 1052 SZ 1052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-13 |