Brand Name | OVITEX REINFORCED TISSUE MATRIX |
Type of Device | SURGICAL MESH |
Manufacturer (Section D) |
AROA BIOSURGERY LTD. |
2 kingsford smith place |
airport oaks, auckland 2022 |
NZ 2022 |
|
Manufacturer (Section G) |
AROA BIOSURGERY LTD. |
2 kingsford smith place |
|
airport oaks, auckland 2022 |
NZ
2022
|
|
Manufacturer Contact |
tina
obrien
|
2 kingsford smith place |
airport oaks, auckland 2022
|
NZ
2022
|
|
MDR Report Key | 13003967 |
MDR Text Key | 285170381 |
Report Number | 3007321028-2021-00025 |
Device Sequence Number | 1 |
Product Code |
FTM
|
UDI-Device Identifier | 09421904065277 |
UDI-Public | 09421904065277 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153633 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/15/2021 |
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 Operator |
Health Professional
|
Device Expiration Date | 06/30/2022 |
Device Model Number | F10254-2020G |
Device Catalogue Number | F10254-2020G |
Device Lot Number | ERT-21A02 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/29/2021 |
Initial Date FDA Received | 12/14/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/06/2021 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 43 YR |
Patient Sex | Female |