Brand Name | VENA SEAL CLOSURE SYSTEM |
Type of Device | AGENT, OCCLUDING, VASCULAR, PERMANENT |
Manufacturer (Section D) |
SAPHEON INC |
951 aviation pkwy ste 900 |
morrisville NC 27560 |
|
Manufacturer (Section G) |
SAPHEON INC |
951 aviation pkwy ste 900 |
|
morrisville NC 27560 |
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
091708734
|
|
MDR Report Key | 6806844 |
MDR Text Key | 83116732 |
Report Number | 3011410703-2017-00330 |
Device Sequence Number | 1 |
Product Code |
PJQ
|
Combination Product (y/n) | N |
Reporter Country Code | KS |
PMA/PMN Number | P140018 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/14/2017 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | SP-101 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/14/2017
|
Initial Date FDA Received | 08/21/2017 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 50 YR |
Patient Weight | 51 |
|
|