MAUDE Adverse Event Report: SOMATICS, LLC SOMATICS; THYMAPAD

Catalog Number EPAD

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

Patient received a minor skin burn during ect treatment.Patient was treated with ointment and sent home as this was a minor event.The thymapad electrode used in treatment was sent to somatics and evaluated.There was a small discoloration at one spot.This is completely indicative of a wet spot of fluid under the electrode.All the energy would be directed at this one small spot instead of over the entire area of the electrode.Additional electrodes from the same lot number were received and tested.The hospital had used about 170 out of 200 of these electrodes without any problems.An additional 15 electrodes were tested at 100% energy at somatics and all performed properly.Results of the testing were discussed with the hospital staff and they were told the minor burn was due to the wet spot under the electrode.The instructions clearly state the pre-tac had to be rubbed into the skin until the area was dry.This was a misuse of the instructions and not a malfunction of the electrode.The hospital staff accepted the results.Somatics is submitting this report to the fda in abundance of caution and to ensure full compliance with 21 cfr part 803.

Event Description

Patient received a minor skin burn during an ect treatment.Treated with ointment and sent home as this was a minor burn.

• Brand Name: SOMATICS
• Type of Device: THYMAPAD
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive; suite 101; venice FL 34292
• Manufacturer (Section G): SOMATICS, LLC; 720 commerce drive; suite 101; venice FL 34292
• Manufacturer Contact: david mirkovich ; 720 commerce drive; suite 101; venice, FL 34292 ; 8472346761
• MDR Report Key: 10522670
• MDR Text Key: 206564533
• Report Number: 1420295-2020-05131
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 882809A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2020

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: No Information
• Device Expiration Date: 10/04/2021
• Device Catalogue Number: EPAD
• Device Lot Number: 929428
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1