Brand Name | LACRICATH LACRIMAL DUCT CATHETER |
Type of Device | LACRIMAL DUCT CATHETER |
Manufacturer (Section D) |
QUEST MEDICAL, INC. |
one allentown parkway |
allen TX 75002 |
|
Manufacturer (Section G) |
QUEST MEDICAL, INC. |
one allentown parkway |
|
allen TX 75002 |
|
Manufacturer Contact |
amy
clendening-wheeler
|
one allentown parkway |
allen, TX 75002
|
|
MDR Report Key | 6713212 |
MDR Text Key | 80247340 |
Report Number | 1649914-2017-00057 |
Device Sequence Number | 1 |
Product Code |
OKS
|
UDI-Device Identifier | 10634624810188 |
UDI-Public | 10634624810188 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K113867 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
08/07/2017 |
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 |
Physician
|
Device Expiration Date | 03/07/2020 |
Device Model Number | LDC315T |
Device Lot Number | 0531747M06 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/16/2017 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/14/2017 |
Initial Date FDA Received | 07/13/2017 |
Supplement Dates Manufacturer Received | 06/14/2017 06/14/2017
|
Supplement Dates FDA Received | 09/04/2017 11/21/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 03/08/2017 |
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) |
Required Intervention;
|
|
|