MAUDE Adverse Event Report: AXELGAARD MFG. CO., LTD. NEUROSTIMULATION ELECTRODES; ELECTRODE, CUTANEOUS

Device Problems Energy Output Problem (1431); Smoking (1585); Noise, Audible (3273)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 06/21/2022

Event Type  Injury  

Event Description

Neuromuscular electrical stimulation to pt's b tibialis anterior for foot drop using russian stim.This was the 4th session and the intensity was at 96 ma, had been using 99-100 ma x 20 min's.Today after 13 min's i heard crackling and then saw smoke coming from one of the 2 electrodes on r le.This resulted in third degree burns to the patient.As of 7/28/2022 the medical device is still with the manufacturer for testing.Fda safety report id# (b)(4).

• Brand Name: NEUROSTIMULATION ELECTRODES
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): AXELGAARD MFG. CO., LTD.
• MDR Report Key: 15146174
• MDR Text Key: 297047195
• Report Number: MW5111204
• Device Sequence Number: 3
• 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: 07/28/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White