MAUDE Adverse Event Report: Shenzhen Dongdixin Technology Co., Ltd. Richmar TheraTouch CX4 Combination E-stim/ Ultrasound Clinical Device (4-chan; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Model Number	DQ8200
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Full thickness (Third Degree) Burn (2696)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive medical was notified of an incident involving an electrotherapy device by an attorney letter who reported that during a physical therapy session, a malfunction of the device caused a third-degree burn to the end user's skin on her right leg and permanent disfigurement to her body.As part of its complaint review and evaluation process, drive medical will also notify the manufacturer of the product about this complaint.

• Brand Name: Richmar TheraTouch CX4 Combination E-stim/ Ultrasound Clinical Device (4-chan
• Common Device Name: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): Shenzhen Dongdixin Technology Co., Ltd.; floor 1-2, no.3 building; fanshen xusheng industrial; nansha, shenzhen guangdong 51810 8; CH 518108
• MDR Report Key: 50515584
• Report Number: 2438477-2026-00057
• Device Sequence Number: 15780283
• Product Code: GZJ
• UDI-Device Identifier: 00092237621462
• UDI-Public: (01)00092237621462
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2026
• Report Date (Section F): 08/31/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DQ8200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/03/2026
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/31/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Sex: Female
• Date Report Sent to FDA: 08/31/2026