MAUDE Adverse Event Report: DYNATRONICS DYANTRONICS; STIMULATOR

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Burn(s) (1757)

Event Date 09/21/2021

Event Type  Injury  

Event Description

During electrical stimulation therapy, patient received a burn to the skin distal to the left malleolus patient was receiving inferential stimulation premod mode on the left popliteal fossa/pes anserine and left achilles tendon.Intensity was adjusted to patient's tolerance.About 12 minutes into the therapy, the patient verbalized increased intensity and increased discomfort.The physical therapist removed the electrodes.Ice packs were applied and skin was inspected.Skin was intact without breakdown or irritation.Patient called a five hours later and stated that she found blisters on her ankle when she had an itch.The patient now has open burn wound about the size of quarter.Patient' lower left leg is in ilizarov external fixator.Patient's listed weight is an estimate.

• Brand Name: DYANTRONICS
• Type of Device: STIMULATOR
• Manufacturer (Section D): DYNATRONICS; salt lake city UT
• MDR Report Key: 12727822
• MDR Text Key: 279629356
• Report Number: 12727822
• Device Sequence Number: 1
• Product Code: GXY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/07/2021

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
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/22/2021
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 120