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 632211-G manufactured by Vascutek Ltd.
Report Number | 9612515-2019-00012 |
MDR Report Key | 8734304 |
Report Source | DISTRIBUTOR,FOREIGN |
Date Received | 2019-06-26 |
Date of Report | 2019-06-25 |
Date of Event | 2019-05-25 |
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 | 2019-03-30 |
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 | 632211-G |
Lot Number | 17713202 2012 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | 2 MO |
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 |