Brand Name | GELSOFT PLUS STRAIGHT |
Type of Device | GELSOFT PLUS STRAIGHT |
Manufacturer (Section D) |
VASCUTEK LTD. |
newmains avenue |
inchinnan business park |
glasgow,, renfrewshire PA4 9 RR, |
UK PA4 9RR, |
|
Manufacturer (Section G) |
VASCUTEK LTD. |
newmains avenue |
inchinnan business park |
glasgow,, renfrewshire PA4 9 RR, |
UK
PA4 9RR,
|
|
Manufacturer Contact |
jason
whittle
|
newmains avenue |
inchinnan |
glasgow, PA49R-R
|
UK
PA49RR
|
|
MDR Report Key | 18613675 |
MDR Text Key | 334206556 |
Report Number | 9612515-2024-00004 |
Device Sequence Number | 1 |
Product Code |
DSY
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K830016 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Study |
Reporter Occupation |
Physician
|
Remedial Action |
Patient Monitoring |
Type of Report
| Initial,Followup |
Report Date |
02/27/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/31/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 06/30/2002 |
Device Catalogue Number | 633010P-G |
Device Lot Number | 17871215 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/04/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/24/2019 |
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 | 74 YR |
Patient Sex | Male |
|
|