MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA INTELECT LEGEND XT ELECTROTHERAPY SYSTEM 4 CHANNEL WITH CART; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number 55433C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Erythema (1840)

Event Date 04/11/2023

Event Type  Injury  

Event Description

Patient was seen in physical therapy treatment on (b)(6) 2023.Therapist applied electrical stimulation treatment to the lower back region for pain control.At completion of treatment, skin inspection revealed skin erythema under the electrodes.Patient reported no discomfort during or after the treatment.Patient attended pre-scheduled appointment with her physician who evaluated the area and prescribed a topical cream for treatment.Patient has been attending pt treatments since the incident.

• Brand Name: CHATTANOOGA INTELECT LEGEND XT ELECTROTHERAPY SYSTEM 4 CHANNEL WITH CART
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO, LLC
• MDR Report Key: 16911123
• MDR Text Key: 315106378
• Report Number: MW5117458
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/08/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 55433C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 142 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White