Brand Name | OPTIMIZED POSITIONING SYSTEM |
Type of Device | OPTIMIZED POSITIONING SYSTEM |
Manufacturer (Section D) |
OPTIMIZED ORTHO PTY LTD |
17 bridge street |
pymble, nsw 2073 |
AS
2073 |
|
Manufacturer (Section G) |
OPTIMIZED ORTHO PTY LTD |
17 bridge street |
|
pymble, nsw 2073 |
AS
2073
|
|
Manufacturer Contact |
james
tai
|
17 bridge street |
pymble, nsw 2073
|
AS
2073
|
|
MDR Report Key | 13520168 |
Report Number | 3012916784-2022-00112 |
Device Sequence Number | 1 |
Product Code |
PBF
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K192656 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/30/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/14/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
|
Device Model Number | OPSINSIGHT |
Device Lot Number | MAT_AS_19092 |
Was Device Available for Evaluation? |
No Answer Provided
|
Date Manufacturer Received | 02/10/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Treatment Data |
Date Received: 02/14/2022 Patient Sequence Number: 1 |
|
|