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

Model Number	554-3003-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A user reported that a patient developed an infection sometime after treatment with a tenex health device.The cause of the infection is unclear.The user did not imply that the infection was due to the device or treatment.He noted that it could be due to patient compliance or post-procedure care.The patient was treated with antibiotics.
Additional Manufacturer Narrative
The procedure / incident date was not reported, so the date of reporting on (b)(6) 2021 was entered for the incident date.Review of production records did not reveal any anomalies or issues that could be related to the reported incident.
Event or Problem Description
A user reported that a patient developed an infection sometime after treatment with a tenex health device.The cause of the infection is unclear.The user did not imply that the infection was due to the device or treatment.He noted that it could be due to patient compliance or post-procedure care.The patient was treated with antibiotics.
Additional Manufacturer Narrative
The procedure / incident date was not reported, so the date of reporting on (b)(6) 2021 was entered for the incident date.Review of production records did not reveal any anomalies or issues that could be related to the reported incident.
Additional Manufacturer Narrative
Follow-up report #01.Additional information was reported.The incident date was provided.User suspected that the patient infection may have been related to a thermal burn in tissue during the procedure with the tenex health device.Also, the patient may have had diabetes mellitus type 2 and another autoimmune disease.

• Brand Name: TXB TISSUE REMOVAL SYSTEM - MICROTIP
• Common Device Name: 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 ; 9492380822
• MDR Report Key: 13115436
• Report Number: 1000135560-2021-00062
• Device Sequence Number: 19988696
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: (01)00857156006093(10)2232101(17)230811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/11/2023
• Device Model Number: 554-3003-001
• Device Catalogue Number: 554-3003-001
• Device Lot Number: 2232101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown