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
o'brien
|
2 kingsford smith place |
airport oaks, auckland 2022
|
NZ
2022
|
|
MDR Report Key | 12595175 |
MDR Text Key | 278759100 |
Report Number | 3007321028-2021-00013 |
Device Sequence Number | 1 |
Product Code |
FTM
|
UDI-Device Identifier | 09421904065116 |
UDI-Public | 09421904065116 |
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 |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/08/2021 |
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 | 08/13/2018 |
Device Model Number | F10246-1620P |
Device Catalogue Number | F10246-1620P |
Device Lot Number | ERT-6I10 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/22/2021 |
Initial Date FDA Received | 10/07/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/28/2016 |
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 | 73 YR |
Patient Weight | 81 |