MAUDE Adverse Event Report: CHATTANOOGA GROUP/ DJO,LLC CHATTANOOGA INTELECT LEGEND XT; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 2760

Patient Problems Device Overstimulation of Tissue (1991); Superficial (First Degree) Burn (2685)

Event Date 09/08/2023

Event Type  Injury  

Event Description

Chattanooga ¿us/es¿ combo machine ifc setting used in normal fashion.All equipment seemed to be in good order.Current had to be adjusted during the treatments due to onset of very uncomfortable sensations during treatment seven electrical burns occurred out of eight electrodes sites during the two dates of treatment.Reference report: mw5146493.

• Brand Name: CHATTANOOGA INTELECT LEGEND XT
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): CHATTANOOGA GROUP/ DJO,LLC
• MDR Report Key: 17868728
• MDR Text Key: 325108441
• Report Number: MW5146492
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 09/19/2023

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: 2760
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 141 KG