Brand Name | GESLOFT |
Type of Device | GESLOFT DOUBLE BIFURCATE |
Manufacturer (Section D) |
VASCUTEK LTD |
newmains avenue |
inchinnan |
glasgow, renrewshire PA49R R |
UK PA49RR |
|
Manufacturer (Section G) |
VASCUTEK LTD |
newmains avenue |
inchinnan |
glasgow, renrewshire PA49R R |
UK
PA49RR
|
|
Manufacturer Contact |
jason
whittle
|
newmains avenue |
inchinnan |
glasgow, renrewshire PA49R-R
|
UK
PA49RR
|
|
MDR Report Key | 15102475 |
MDR Text Key | 296569661 |
Report Number | 9612515-2022-00009 |
Device Sequence Number | 1 |
Product Code |
MAL
|
UDI-Device Identifier | 05037881110011 |
UDI-Public | 05037881110011 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | P890045/S1 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
07/26/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/26/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2023 |
Device Model Number | GESLOFT DOUBLE BIFURCATE |
Device Catalogue Number | 631809DB |
Device Lot Number | 17299100 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/01/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/18/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|