Brand Name | TX2 TISSUE REMOVAL SYSTEM - MICROTIP |
Type of Device | INSTRUMENT, ULTRASONIC SURGICAL |
Manufacturer (Section D) |
TENEX HEALTH, INC. |
26902 vista terrace |
lake forest CA 92630 8123 |
|
Manufacturer (Section G) |
TENEX HEALTH, INC. |
26902 vista terrace |
|
lake forest CA 92630 |
|
Manufacturer Contact |
david
vancelette
|
26902 vista terrace |
lake forest, CA 92630
|
9492388220
|
|
MDR Report Key | 18691286 |
MDR Text Key | 336403886 |
Report Number | 1000135560-2024-00008 |
Device Sequence Number | 1 |
Product Code |
LFL
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K153299 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/09/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/12/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 554-2003-001 |
Device Catalogue Number | 554-2003-001 |
Device Lot Number | 1642201 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 01/24/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/02/2022 |
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 Sex | Male |
Patient Ethnicity | Non Hispanic |
|
|