Brand Name | TENEX HEALTH TX SYSTEM - MICROTIP |
Type of Device | ULTRASONIC SURGICAL ASPIRATOR |
Manufacturer (Section D) |
TENEX HEALTH |
26902 vista terrace |
lake forest CA 92630 |
|
Manufacturer (Section G) |
TENEX HEALTH |
26902 vista terrace |
|
lake forest CA 92630 |
|
Manufacturer Contact |
alison
baxter
|
26902 vista terrace |
lake forest, CA 92630
|
9494547500
|
|
MDR Report Key | 6620719 |
MDR Text Key | 76942350 |
Report Number | 3009750704-2017-00081 |
Device Sequence Number | 1 |
Product Code |
LFL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153299 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/07/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/07/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 12/31/2017 |
Device Catalogue Number | 554-2003-001 |
Device Lot Number | 01717-01 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/07/2017 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/22/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/03/2017 |
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) |
Other;
|
Patient Age | 45 YR |
Patient Weight | 127 |