MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for COR-KNOT MIS COMBO KIT 5MM 031082 manufactured by Lsi Solutions Inc..
[137171199]
The cor-knot device would not release.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084165 |
| MDR Report Key | 8358909 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-02-14 |
| Date Added to Maude | 2019-02-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COR-KNOT MIS COMBO KIT 5MM |
| Generic Name | INSTRUMENT, LIGATURE PASSING AND KNOTTING |
| Product Code | HCF |
| Date Received | 2019-02-19 |
| Model Number | 031082 |
| Lot Number | 730972 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS INC. |
| Manufacturer Address | VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |