Brand Name | MERITS |
Type of Device | VISION SPORT |
Manufacturer (Section D) |
MERITS HEALTH PRODUCTS CO.,LTD |
no. 18. jingke rd,tpmt park, |
nantun district |
taichung city, 40852 |
CH 40852 |
|
MDR Report Key | 11637771 |
MDR Text Key | 247024143 |
Report Number | 9680333-2021-00002 |
Device Sequence Number | 1 |
Product Code |
ITI
|
UDI-Device Identifier | 04714379292541 |
UDI-Public | 04714379292541 |
Combination Product (y/n) | N |
PMA/PMN Number | K012802 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Remedial Action |
Replace |
Type of Report
| Initial,Followup |
Report Date |
03/23/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | P326A |
Initial Date Manufacturer Received |
03/11/2021 |
Initial Date FDA Received | 04/08/2021 |
Supplement Dates Manufacturer Received | 03/11/2021
|
Supplement Dates FDA Received | 05/12/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 65 YR |
|
|