MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-06-26 for GELSOFT 631407 manufactured by Vascutek Ltd.
| Report Number | 9612515-2019-00010 |
| MDR Report Key | 8734316 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-06-26 |
| Date of Report | 2019-06-25 |
| Date of Event | 2019-05-02 |
| Date Facility Aware | 2019-05-29 |
| Report Date | 2019-05-29 |
| Date Reported to Mfgr | 2019-05-29 |
| Date Mfgr Received | 2019-05-29 |
| Device Manufacturer Date | 2016-01-06 |
| Date Added to Maude | 2019-06-26 |
| 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 | MR JASON WHITTLE |
| 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 BIFURCATE |
| Product Code | MAL |
| Date Received | 2019-06-26 |
| Catalog Number | 631407 |
| Lot Number | 375738 8500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-06-26 |