Brand Name | CUSTOM-PAK SURGICAL PROCEDURE PACK |
Type of Device | GENERAL SURGERY TRAY (KIT) |
Manufacturer (Section D) |
ALCON RESEARCH, LTD. - HOUSTON |
9965 buffalo speedway |
houston TX 77054 |
|
Manufacturer (Section G) |
ALCON RESEARCH, LTD. - HOUSTON |
9965 buffalo speedway |
|
houston TX 77054 |
|
Manufacturer Contact |
nadia
bailey
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8176152230
|
|
MDR Report Key | 6878396 |
MDR Text Key | 86705631 |
Report Number | 1644019-2017-00724 |
Device Sequence Number | 1 |
Product Code |
LRO
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K880961 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/03/2018 |
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 | 10/14/2018 |
Device Catalogue Number | 11429 |
Device Lot Number | 2022388H |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/08/2017 |
Initial Date FDA Received | 09/20/2017 |
Supplement Dates Manufacturer Received | 11/15/2017 12/07/2017
|
Supplement Dates FDA Received | 12/05/2017 01/03/2018
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/20/2017 |
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 |
Treatment | DUOVISC, VISCOELASTIC SYSTEM |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 51 YR |