MAUDE Adverse Event Report: DYNATRONICS CORP. DYNATRONICS CORP ULTRASOUND STIMULATION UNIT; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number D708

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/27/2021

Event Type  Injury  

Event Description

Patient had physical therapy appointment on (b)(6) 2021.During appointment e-stim treatment was performed.After removal of electrodes, skin appeared fine.The next day, (b)(6) 2021 the patient reported that she had developed a single, small circular burn-like sore in the area where the electrodes were placed.Fda safety report id# (b)(4).

• Brand Name: DYNATRONICS CORP ULTRASOUND STIMULATION UNIT
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DYNATRONICS CORP.
• MDR Report Key: 12745025
• MDR Text Key: 280175166
• Report Number: MW5105094
• Device Sequence Number: 1
• Product Code: IMI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D708
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 99