MAUDE Adverse Event Report: TENEX HEALTH, INC. TENEX HEALTH TX SYSTEM - WITH TXP MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number 554-3003-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Discharge (2225)

Event Date 11/29/2018

Event Type  Injury  

Event Description

Following a procedure with the tenex health tx system, the doctor reported a sinus track development due to heat in the treatment area and a secondary infection.

Manufacturer Narrative

Follow-up report #01.Further information was obtained from the reporting physician.It was determined that there was not a secondary infection as previously reported.It was also determined that the sinus track "development" was an issue of excessive drainage or discharge from the treatment area.It is unclear if heat from the device was a factor or if there were any tissue burns.

Event Description

Following a procedure with the tenex health tx system, the doctor reported a sinus track development due to heat in the treatment area.The issue involved extended drainage from the treatment area, apparently due to delayed healing of the sinus track.It was unclear if there were any tissue burns.

• Brand Name: TENEX HEALTH TX SYSTEM - WITH TXP MICROTIP
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• MDR Report Key: 8426933
• MDR Text Key: 139034692
• Report Number: 1000135560-2019-00011
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K181367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

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 Model Number: 554-3003-001
• Device Catalogue Number: 554-3003-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/16/2019
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other