MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-05-17 for GELSEAL GELSEAL STRAIGHT 435028 manufactured by Vascutek Ltd..
[108505366]
Device evaluated by manufacturer device received on (b)(6) 2018 - evaluation is ongoing however will not be complete before this report is submitted. (b)(4) method code: process evaluation - a review was carried out of all qc and manufacturing records manufacturing review - review of all qc and manufacturing records carried out sterilisation process review - review of sterilisation cycle performed actual device not evaluated - device received on 15th may 2018 - evaluation is ongoing at time of this report submission. Results code no failure detected - no issue was found on review of all qc, manufacturing and sterilisation records for this batch of grafts. Results pending completion of evaluation - evaluation of device started but not complete at time of submission. Vascutek has contacted site several times for further information, however information received to date has been limited and no images of event or precise details of the leakage observed have been received vascutek will provided an update & evaluation in next follow up / final report.
Patient Sequence No: 1, Text Type: N, H10
[108505367]
Event was reported to vascutek as follows: during procedure it was found that prosthesis was perforated along entire length. Due to the patients condition the bleeding site was stitched. No patient death or serious harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612515-2018-00004 |
| MDR Report Key | 7521273 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-05-17 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-04-19 |
| Date Facility Aware | 2018-04-19 |
| Report Date | 2018-04-19 |
| Date Reported to Mfgr | 2018-04-19 |
| Date Mfgr Received | 2018-04-19 |
| Device Manufacturer Date | 2016-01-31 |
| Date Added to Maude | 2018-05-17 |
| 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 | GELSEAL |
| Generic Name | GELSEAL GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS |
| Product Code | MAL |
| Date Received | 2018-05-17 |
| Returned To Mfg | 2018-05-15 |
| Model Number | GELSEAL STRAIGHT |
| Catalog Number | 435028 |
| Lot Number | 377296 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 15 MO |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2018-05-17 |