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) |
ST PAUL |
1265 grey fox rd. |
|
st. paul MN 55112 |
|
Manufacturer Contact |
david
halverson
|
6000 nathan lane north |
lauziere, europarc de pichaury |
minneapolis, MN 55442
|
|
MDR Report Key | 11076456 |
MDR Text Key | 223725483 |
Report Number | 3012307300-2020-12774 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10610586027239 |
UDI-Public | 10610586027239 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K040636 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/28/2020 |
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 |
No Information
|
Device Expiration Date | 10/23/2022 |
Device Model Number | 21-7302-24 |
Device Catalogue Number | 21-7302-24 |
Device Lot Number | 17X711 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/30/2020 |
Initial Date FDA Received | 12/28/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/30/2017 |
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 |
|
|