MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-14 for GELSOFT GELSOFT BIFURCATE 631608-G manufactured by Vascutek Ltd..
[139104512]
(b)(4). This report is being submitted as an initial / final report. As no device is being returned for further investigation, vascutek ltd. Now considers this complaint closed however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
Patient Sequence No: 1, Text Type: N, H10
[139104513]
Event was reported to vascutek ltd. As follows: "after blood flow release the graft showed a leakage at the sight of the bifurcate junction. The surgeon applied a few stitches to stop the bleeding".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612515-2019-00003 |
| MDR Report Key | 8419600 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-02-13 |
| Date Facility Aware | 2019-02-13 |
| Report Date | 2019-02-14 |
| Date Reported to Mfgr | 2019-02-14 |
| Date Mfgr Received | 2019-02-14 |
| Device Manufacturer Date | 2018-10-31 |
| Date Added to Maude | 2019-03-14 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS CAROLYN FORREST |
| Manufacturer Street | NEWMAINS AVENUE INCHINNAN BUSINESS PARK |
| Manufacturer City | RENFREWSHIRE, PA4 9RR |
| Manufacturer Country | UK |
| Manufacturer Postal | PA4 9RR |
| Manufacturer G1 | VASCUTEK LTD. |
| Manufacturer Street | NEWMAINS AVENUE INCHINNAN BUSINESS PARK |
| Manufacturer City | RENFREWSHIRE, PA4 9RR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | PA4 9RR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GELSOFT |
| Generic Name | GELSOFT GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS |
| Product Code | MAL |
| Date Received | 2019-03-14 |
| Model Number | GELSOFT BIFURCATE |
| Catalog Number | 631608-G |
| Lot Number | 17601138-1664 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCUTEK LTD. |
| Manufacturer Address | NEWMAINS AVENUE INCHINNAN BUSINESS PARK RENFREWSHIRE, PA4 9RR UK PA4 9RR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-14 |