MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-31 for KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY 274R manufactured by Cell Marque Corporation.
| Report Number | 1649339-2019-00001 |
| MDR Report Key | 8848973 |
| Date Received | 2019-07-31 |
| Date of Report | 2019-07-30 |
| Date of Event | 2019-06-25 |
| Date Added to Maude | 2019-07-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY |
| Generic Name | KAPPA (EP171) RABBIT MONOCLONAL ANTIBODY |
| Product Code | NJT |
| Date Received | 2019-07-31 |
| Model Number | 274R |
| Catalog Number | 274R |
| Lot Number | 57588, 64775, 57617, 57618 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CELL MARQUE CORPORATION |
| Manufacturer Address | 6600 SIERRA COLLEGE BOULEVARD ROCKLIN CA 95677 US 95677 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-31 |