Brand Name | GELWEAVE |
Type of Device | GELWEAVE STRAIGHT |
Manufacturer (Section D) |
VASCUTEK LTD |
newmains avenue |
inchinnan business park |
renfrewshire, PA4 9 RR |
UK PA4 9RR |
|
Manufacturer (Section G) |
VASCUTEK LTD |
newmains avenue |
inchinnan business park |
renfrewshire, PA4 9 RR |
UK
PA4 9RR
|
|
Manufacturer Contact |
jason
whittle
|
newmains avenue |
inchinnan business park |
renfrewshire, PA4 9-RR
|
UK
PA4 9RR
|
|
MDR Report Key | 13007985 |
MDR Text Key | 290389395 |
Report Number | 9612515-2021-00028 |
Device Sequence Number | 1 |
Product Code |
DSY
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K952293 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/31/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | GELWEAVE STRAIGHT |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/17/2021
|
Initial Date FDA Received | 12/15/2021 |
Supplement Dates Manufacturer Received | 11/17/2021
|
Supplement Dates FDA Received | 01/31/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
Patient Age | 50 YR |
|
|