Brand Name | ONX MITRAL CONFORM 25/33 |
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 | 14742883 |
MDR Text Key | 295040082 |
Report Number | 1649833-2022-00029 |
Device Sequence Number | 1 |
Product Code |
LWQ
|
UDI-Device Identifier | 00851788001303 |
UDI-Public | 851788001303 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P000037 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
08/18/2022 |
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? |
No
|
Device Model Number | ONXMC-25/33 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 05/19/2022 |
Initial Date Manufacturer Received |
05/19/2022
|
Initial Date FDA Received | 06/20/2022 |
Supplement Dates Manufacturer Received | 05/19/2022
|
Supplement Dates FDA Received | 08/18/2022
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
Hospitalization;
|
Patient Age | 39 YR |
Patient Sex | Male |
|
|