Brand Name | TEST |
Type of Device | TEST |
Manufacturer (Section D) |
COOPERVISION LENS CARE LTD. |
mace industrial estate |
ashford, kent TN24 8EP |
UK TN24 8EP |
|
Manufacturer (Section G) |
COOPERVISION LENS CARE LTD. |
mace industrial estate |
|
ashford, kent TN24 8EP |
UK
TN24 8EP
|
|
Manufacturer Contact |
melissa
torpey
|
5870 stoneridge drive |
suite 1 |
pleasanton, CA 94588
|
5857569874
|
|
MDR Report Key | 11541686 |
MDR Text Key | 241427662 |
Report Number | 9615939-2021-00001 |
Device Sequence Number | 1 |
Product Code |
LPN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130734 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/22/2021 |
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 |
Lay User/Patient
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/22/2021 |
Initial Date FDA Received | 03/22/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|