Brand Name | SIMON NITINOL IVC FILTER |
Type of Device | FILTER, INTRAVASCULAR, CARDIOVASCULAR |
Manufacturer (Section D) |
BARD PERIPHERAL VASCULAR, INC. |
|
|
MDR Report Key | 15163592 |
MDR Text Key | 297347998 |
Report Number | MW5111267 |
Device Sequence Number | 1 |
Product Code |
DTK
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/02/2022 |
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
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/03/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 48 YR |
Patient Sex | Male |
Patient Weight | 86 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |
|
|