Brand Name | OMNILINK ELITE PERIPHERAL STENT SYSTEM |
Type of Device | PERIPHERAL STENT DELIVERY SYSTEM |
Manufacturer (Section D) |
ABBOTT VASCULAR |
26531 ynez rd. |
temecula CA 92591 4628 |
|
Manufacturer (Section G) |
ABBOTT VASCULAR, REG # 3005718570 (P099) |
cashel road |
|
clonmel tipperary |
EI
|
|
Manufacturer Contact |
lindsey
bell
|
26531 ynez rd. |
temecula, CA 92591-4628
|
9519143996
|
|
MDR Report Key | 19209177 |
MDR Text Key | 341354316 |
Report Number | 2024168-2024-05224 |
Device Sequence Number | 1 |
Product Code |
NIO
|
UDI-Device Identifier | 08717648142765 |
UDI-Public | (01)08717648142765(17)251231(10)2070541 |
Combination Product (y/n) | N |
Reporter Country Code | IN |
PMA/PMN Number | P110043 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/29/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 11012-29 |
Device Lot Number | 2070541 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/16/2024
|
Initial Date FDA Received | 04/29/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/05/2022 |
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 |
Treatment | 0.035 GUIDE WIRE. |
Patient Outcome(s) |
Required Intervention;
Disability;
|