Brand Name | CUSTOM-PAK SURGICAL PROCEDURE PACK |
Type of Device | GENERAL SURGERY TRAY (KIT) |
Manufacturer (Section D) |
ALCON RESEARCH, LLC - HOUSTON |
9965 buffalo speedway |
houston TX 77054 |
|
Manufacturer (Section G) |
ALCON RESEARCH, LLC - HOUSTON |
9965 buffalo speedway |
|
houston TX 77054 |
|
Manufacturer Contact |
jonathan
schlech
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8007579780
|
|
MDR Report Key | 19061312 |
MDR Text Key | 339614690 |
Report Number | 1644019-2024-00650 |
Device Sequence Number | 1 |
Product Code |
LRO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K880961 |
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 |
Report Date |
04/08/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/08/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | ASKU |
Device Lot Number | ASKU |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 03/13/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | SURGICAL PRODUCT, UNSPECIFIED. |