Brand Name | CORMATRIX ECM FOR CAROTID REPAIR |
Type of Device | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
Manufacturer (Section D) |
AZIYO BIOLOGICS, INC. |
1100 old ellis road |
ste 1200 |
roswell GA 30076 |
|
Manufacturer (Section G) |
AZIYO BIOLOGICS, INC. |
1100 old ellis road |
ste 1200 |
roswell GA 30076 |
|
Manufacturer Contact |
andrew
green
|
1100 old ellis road |
ste 1200 |
roswell, GA 30076
|
|
MDR Report Key | 7109951 |
MDR Text Key | 94635261 |
Report Number | 3005619880-2017-00036 |
Device Sequence Number | 1 |
Product Code |
DXZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K140789 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/12/2017 |
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 |
Physician
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/19/2017 |
Initial Date FDA Received | 12/12/2017 |
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;
|
Patient Age | 73 YR |
Patient Weight | 83 |
|
|