MAUDE Adverse Event Report: SOMATICS, LLC SOMATICS; THYMAPAD STIMULUS ELECTRODE

Model Number EPAD

Device Problems Device Emits Odor (1425); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn, Thermal (2530)

Event Date 11/29/2013

Event Type  malfunction  

Manufacturer Narrative

Patient received an ect treatment.During treatment doctor noticed a burning smell.When the patient was in pacu, the nurse noticed a small burn where the thymapad had been.The patient also had a metal rod pierced through the eyebrow near the skin burn site.The skin was treated with bacitracin and the patient sent home.No further treatments were administered to the skin.The patient was told to remover the metal rod before any further ect treatments.This event was reported to the fda by the risk management of the hospital, 12/10 2013, number mw3516403.At that time, somatics did not consider this an event caused by the thymapad, rather the metal piercing.The patient was told to remove the metal rod before any further ect treatment and the patient was sent home after the bacitracin application with no further medical treatments.This led the company to consider the thymapad was not the cause of the event.Upon further consideration the company has determined that it should report this event out of abundance of caution and to ensure full compliance with 21 cfr part 803.[mw 3516403.Pdf].

Event Description

Patient with a metal rod inserted in the eyebrow received an ect treatment with a thymapad stimulus electrode.During the treatment, the physician smelled a burning odor.In the pacu, the nurse removed the thymapad and noticed a very small skin burn.The skin was treated with bacitracin and the patient was sent home.The patient was told to remove the metal rod prior to receiving any future ect treatments.

• Brand Name: SOMATICS
• Type of Device: THYMAPAD STIMULUS ELECTRODE
• Manufacturer (Section D): SOMATICS, LLC; suite 101; 720 commerce drive; venice FL 34292
• Manufacturer (Section G): SOMATICS, LLC; suite 101; 720 commerce drive; venice FL 34292
• Manufacturer Contact: david mirkovich ; suite 101; 720 commerce drive; venice, FL 34292 ; 8006426761
• MDR Report Key: 8445243
• MDR Text Key: 139856773
• Report Number: 1420295-2019-00003
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 882809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: EPAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 3516403
• Patient Sequence Number: 1