MAUDE Adverse Event Report: Shenzhen Dongdixin Technology Co., Ltd. Richmar TheraTouch CX4 Combination E-stim/ Ultrasound Clinical Device (4-chan

Model Number	DQ8200 (Manufacturer# CT2400)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/30/2025
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.
Additional Manufacturer Narrative
This event was also reported to fda by the importer under importer report no.2438477-2026-00057.(1) investigation and analysis methodology: the mechanism of electrophysical rehabilitation devices may cause skin burns in patients, including joule heating burns and chemical burns.Potential causes include device-related issues (e.G., substandard electrodes leading to concentrated current density, device malfunction causing excessive instantaneous current), operation-related issues (e.G., excessive treatment intensity, prolonged treatment duration, adjusting electrodes before the device is stopped, electrodes placed too close together), and patient-related factors such as potential allergy to the gel.Since no device serial number was provided, the corresponding batch and dhr records cannot be retrieved.As the information provided by the customer is limited, a request for supplementary information has been sent to the customer by email.(2) failure mode(s)/mechanism(s) and associated component(s): based on the currently available information, a definitive device failure mode cannot be confirmed.Since no device serial number was provided, the corresponding batch and dhr records cannot be retrieved.A causal conclusion of device failure cannot be established based on the available information.If supplementary information becomes available later, further analysis of this issue will continue.(3) conclusions: a causal conclusion of device failure cannot be established based on the available information.The relevant information has been incorporated into the complaint file for traceability and fda review.

• Brand Name: Richmar TheraTouch CX4 Combination E-stim/ Ultrasound Clinical Device (4-chan
• Common Device Name: TheraTouch CX4 Combination E-stim/ Ultrasound Clinical Device
• Manufacturer (Section D): Shenzhen Dongdixin Technology Co., Ltd.; floor 1-2, no.3 building, fans; xusheng industrial estate xili; shenzhen, guangdong 51810 8; CH 518108
• Manufacturer (Section G): Shenzhen Dongdixin Technology Co., Ltd.; floor 1-2, no.3 building, fans; xusheng industrial estate xili; shenzhen, guangdong 51810 8; CH 518108
• Manufacturer Contact: siping yuan ; floor 1-2, no.3 building, fans; xusheng industrial estate xili; shenzhen, guangdong 51810-8 ; CH 518108
• MDR Report Key: 50880442
• Report Number: 3005170249-2026-00005
• Device Sequence Number: 13207139
• Product Code: GZJ
• UDI-Device Identifier: 00092237621462
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K150436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DQ8200 (Manufacturer# CT2400)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female