Brand Name | AMPLATZER VASCULAR PLUG II |
Type of Device | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION |
Manufacturer (Section D) |
ABBOTT MEDICAL |
5050 nathan lane n |
plymouth MN 55442 |
|
Manufacturer (Section G) |
ABBOTT MEDICAL REG# 2135147 |
5050 nathan ln n |
|
plymouth MN 55442 |
|
Manufacturer Contact |
karen
krouse
|
5050 nathan lane n |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 18743576 |
MDR Text Key | 335811137 |
Report Number | 2135147-2024-00761 |
Device Sequence Number | 1 |
Product Code |
KRD
|
UDI-Device Identifier | 00811806010342 |
UDI-Public | 00811806010342 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K071699 |
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,Followup |
Report Date |
03/11/2024 |
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 Catalogue Number | 9-AVP2-003 |
Device Lot Number | 9074477 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 02/20/2024 |
Supplement Dates Manufacturer Received | 03/07/2024
|
Supplement Dates FDA Received | 03/11/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/2023 |
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 |
|
|