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

Model Number 554-3003-001

Device Problem Temperature Problem (3022)

Patient Problems Bacterial Infection (1735); Erythema (1840); Pain (1994); Ambulation Difficulties (2544); Superficial (First Degree) Burn (2685); Swelling/ Edema (4577)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

Note that the patient's medwatch report included a statement that "infection is noted as possible adverse reaction to procedure, but thermal burn was not mentioned as possible reaction to this procedure." burns are, in fact, included in the list of adverse effects in the ifu provided with every device.

Event Description

A patient reported through the fda medwatch program that they had experienced a thermal burn and an infection following a procedure with a tenex health tx system device.Symptoms manifested five days postoperatively and included pain, swelling, redness and an inability to bear weight on the operative foot.

• Brand Name: TX SYSTEM - TXB 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: 17881609
• MDR Text Key: 325040142
• Report Number: 1000135560-2023-00046
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: (01)00857156006093
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• 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
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female