MAUDE Adverse Event Report: SOMATICS LLC EPAD THYMAPAD STIMULUS ELECTRODES FOR ECT TREATMENT; ELECTRODE, CUTANEOUS

Lot Number 033549

Device Problems Smoking (1585); Sparking (2595)

Patient Problem Burn(s) (1757)

Event Date 12/10/2021

Event Type  Injury  

Event Description

Sparks and smoke noted from ect electrode during ect treatment.Electrode immediately removed from patient right temple.Burn noted on edge of electrode.Burn also noted on patient's right temple.Patient sent to emergency room for evaluation of burn.

• Brand Name: EPAD THYMAPAD STIMULUS ELECTRODES FOR ECT TREATMENT
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): SOMATICS LLC; 720 commerce drive, unit 101 venice; florida FL 34292
• MDR Report Key: 13011852
• MDR Text Key: 282379754
• Report Number: MW5106067
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/10/2021

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
• Device Lot Number: 033549
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White