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

Model Number 554-3003-001

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 12/31/2019

Event Type  Injury  

Event Description

Report of a thermal burn following a procedure with a txb microtip was discovered in a webinar presented by a physician.The physician reported that the injury occurred in a procedure performed by a different physician.The physician used the txb microtip to treat a chronic nonunion talar spur.A thermal burn and opened blister were evident on day 2 after the procedure.Sharp debridement was used to remove necrotic tissue.Then aquacel foam dressing was applied to the burn site.The burn proceeded to heal.

• Brand Name: TENEX HEALTH TX SYSTEM - WITH 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: 10759983
• MDR Text Key: 213866588
• Report Number: 1000135560-2020-00044
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/29/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/29/2020
• 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