Brand Name | ONX AORTIC CONFORM EXT 25 |
Type of Device | HEART-VALVE, MECHANICAL |
Manufacturer (Section D) |
ON-X LIFE TECHNOLOGIES, INC. |
1300 e. anderson ln., bldg. b |
austin TX 78752 |
|
Manufacturer (Section G) |
ON-X LIFE TECHNOLOGIES, INC. |
1300 e. anderson ln., bldg. b |
|
austin TX 78752 |
|
Manufacturer Contact |
rochelle
maney
|
1655 roberts blvd., nw |
kennesaw, GA 30144
|
7704193355
|
|
MDR Report Key | 12917285 |
MDR Text Key | 286645448 |
Report Number | 1649833-2021-00043 |
Device Sequence Number | 1 |
Product Code |
LWQ
|
UDI-Device Identifier | 00851788001471 |
UDI-Public | 851788001471 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | P000037 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Study,Health Professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
12/02/2021 |
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 Expiration Date | 05/21/2021 |
Device Model Number | ONXACE-25 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 11/04/2021 |
Initial Date Manufacturer Received |
11/04/2021
|
Initial Date FDA Received | 12/02/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
|
Patient Sex | Male |
|
|