MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-26 for COR-KNOT * 030800 manufactured by Lsi Solutions, Inc..
[5597813]
Corknot device was sticky and did not cut after using it 4-5 times.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 4651381 |
MDR Report Key | 4651381 |
Date Received | 2015-03-26 |
Date of Report | 2015-03-26 |
Date of Event | 2015-03-23 |
Report Date | 2015-03-26 |
Date Reported to FDA | 2015-03-26 |
Date Reported to Mfgr | 2015-04-02 |
Date Added to Maude | 2015-04-02 |
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 | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | COR-KNOT |
Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYESTER |
Product Code | GAS |
Date Received | 2015-03-26 |
Model Number | * |
Catalog Number | 030800 |
Lot Number | 75283 |
ID Number | * |
Operator | PHYSICIAN |
Device Availability | Y |
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 | 2015-03-26 |