MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for CORKNOT COMBO KIT 31350 manufactured by Lsi Solutions, Inc..
[53727480]
Patient Sequence No: 1, Text Type: N, H10
[53727481]
A 2nd mitral valve implant was needed due to a defective suturing device being utilized with the original valve currently being implanted. Per scrub techs, doctor explanting the 1st valve for discard, and requesting to open a 2nd valve. Device and re-load sequestered in dept. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5920485 |
| MDR Report Key | 5920485 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-15 |
| Report Date | 2016-08-24 |
| Date Reported to FDA | 2016-08-24 |
| Date Reported to Mfgr | 2016-08-24 |
| Date Added to Maude | 2016-09-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORKNOT COMBO KIT |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYESTER |
| Product Code | GAS |
| Date Received | 2016-09-01 |
| Catalog Number | 31350 |
| Lot Number | 407707 |
| ID Number | MINI DEVICE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LSI SOLUTIONS, INC. |
| Manufacturer Address | 7796 VICTOR-MENDON RD VICTOR NY 14564 US 14564 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-01 |