Brand Name | CADD |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
ST PAUL |
1265 grey fox rd. |
st. paul MN 55112 |
|
Manufacturer (Section G) |
NULL |
1265 grey fox rd. |
|
st. paul MN 55112 |
|
Manufacturer Contact |
jim
vegel
|
6000 nathan lane north |
7-1-1 akasaka |
minneapolis, MN 55442
|
|
MDR Report Key | 14287271 |
MDR Text Key | 290783654 |
Report Number | 3012307300-2022-07579 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586032370 |
UDI-Public | 10610586032370 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K081156 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/09/2023 |
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 |
Lay User/Patient
|
Device Model Number | 21-7308-24 |
Device Catalogue Number | 21-7308-24 |
Device Lot Number | 4091358 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/08/2022 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/06/2022
|
Initial Date FDA Received | 05/05/2022 |
Supplement Dates Manufacturer Received | 09/27/2022 05/04/2023
|
Supplement Dates FDA Received | 10/18/2022 05/09/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/25/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |