Brand Name | FEMOSTOP GOLD |
Type of Device | CLAMP, VASCULAR |
Manufacturer (Section D) |
ST. JUDE MEDICAL |
p.o. box 998 |
lot 20 b st. |
caguas, puerto rico 00725 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL |
p.o. box 998 |
lot 20 b st. |
caguas, puerto rico 00725 |
|
Manufacturer Contact |
janna
parks
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 15829118 |
MDR Text Key | 303957405 |
Report Number | 2648612-2022-00013 |
Device Sequence Number | 1 |
Product Code |
DXC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K110193 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/11/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/18/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | C11165 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/21/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
|
|