MAUDE Adverse Event Report: TENEX HEALTH TENEX HEALTH TX SYSTEM; INSTRUMENT, ULTRASONIC SURGICAL

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  

Event Description

Tenex procedure to achilles tendon in physician clinic resulted in thermal burns and bacterial infection.Infection is noted as possible adverse reaction to procedure, but thermal burn was not mentioned as possible reaction to this procedure that is considered safe and with few side effects/adverse reaction.Symptoms manifested themselves 5 days post op, with horrible pain, swelling, redness and unable to bear weight on affected foot.I thought thermal burn would cause symptoms sooner than 5 days.

• Brand Name: TENEX HEALTH TX SYSTEM
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH
• MDR Report Key: 17499065
• MDR Text Key: 321051252
• Report Number: MW5122877
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: HYDROCODONE FOR PAIN. ; KEFLEX FOR INFECTION.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White