Brand Name | GELWEAVE EXTRA LONG BIFURCATES |
Type of Device | GELWEAVE EXTRA LONG BIFURCATES |
Manufacturer (Section D) |
VASCUTEK LTD |
newmains avenue |
inchinnan |
glasgow, PA49R R |
UK PA49RR |
|
Manufacturer (Section G) |
VASCUTEK LTD |
newmains avenue |
inchinnan |
glasgow, PA49R R |
UK
PA49RR
|
|
Manufacturer Contact |
jason
whittle
|
newmains avenue |
inchinnan |
glasgow, PA49R-R
|
UK
PA49RR
|
|
MDR Report Key | 18343321 |
MDR Text Key | 330661846 |
Report Number | 9612515-2023-00034 |
Device Sequence Number | 1 |
Product Code |
DSY
|
UDI-Device Identifier | 05037881107660 |
UDI-Public | 05037881107660 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K964665 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Physician
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
12/15/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/18/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 732211XL55-G |
Device Lot Number | 21966271 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/11/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/22/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|