MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-01-24 for COR-KNOT manufactured by Lsi Solutions.
| Report Number | 1320468-2020-00001 |
| MDR Report Key | 9629965 |
| Report Source | LITERATURE |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-01-24 |
| 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 |
| Manufacturer Contact | MR. CHRISTOPHER MILLER |
| Manufacturer Street | 7796 VICTOR-MENDON ROAD |
| Manufacturer City | VICTOR NY 14564 |
| Manufacturer Country | US |
| Manufacturer Postal | 14564 |
| Manufacturer Phone | 5858696665 |
| Manufacturer G1 | LSI SOLUTIONS |
| Manufacturer Street | 7796 VICOR-MENDON ROAD |
| Manufacturer City | VICTOR NY 14564 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14564 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COR-KNOT |
| Generic Name | COR-KNOT DEVICE |
| Product Code | HCF |
| Date Received | 2020-01-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS |
| Manufacturer Address | 7796 VICTOR-MENDON ROAD VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-24 |