Brand Name | 6F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US |
Type of Device | DEVICE, HEMOSTASIS, VASCULAR |
Manufacturer (Section D) |
TERUMO MEDICAL CORPORATION |
2101 cottontail ln. |
somerset NJ 08873 |
|
Manufacturer (Section G) |
TERUMO MEDICAL CORPORATION |
2101 cottontail ln. |
|
somerset NJ 08873 |
|
Manufacturer Contact |
terry
callahan
|
2101 cottontail ln. |
somerset, NJ 08873
|
8002837866
|
|
MDR Report Key | 6865817 |
MDR Text Key | 86502336 |
Report Number | 2243441-2017-00123 |
Device Sequence Number | 1 |
Product Code |
MGB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P930038 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
09/14/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/14/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/28/2018 |
Device Catalogue Number | C610134 |
Device Lot Number | 5918914 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 11/03/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/27/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 67 YR |
Patient Weight | 88 |