MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. ROSCOE; THERA TOUCH EX4 CLINICAL STIM DEVICE

Model Number	DQ7200 (MANUFACTURER# MT2400)
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The end user received treatment that caused temporary immobility where the treatment was performed.The end user has had several doctor visits where she was prescribed anti-inflammatory medication.As reported by the end user the electrodes were placed less than 1" apart.The electrodes that were being used were not chb electrodes.
Additional Manufacturer Narrative
This event was also reported to fda by the importer under importer report no.3012316249-2025-00009.(1) investigation methodology: a complaint investigation was initiated.The manufacturer reviewed the device history records (dhr) for other batch since no serial number was provided and did not identify output abnormalities recorded during production or testing.(2) failure mode/mechanism considerations: a definitive device failure mode could not be confirmed based on currently available information.The reported use conditions[?]very close electrode spacing (<1") and use of non-chb electrodes[?]may affect electrode-skin interface characteristics (effective contact area, current density, impedance/contact quality) and could plausibly contribute to localized adverse effects.The dhr review did not identify manufacturing/test-recorded output abnormalities.(3) conclusions: based on the information available, root cause cannot be definitively determined.Electrode spacing that is too close (<1 inch) and the use of non-chb electrodes may be potential causes of the problem.The dhr review did not reveal output abnormalities recorded during production or testing.Additional reporting on this event will be provided as a supplemental report to this document if more information becomes available.

• Brand Name: ROSCOE
• Common Device Name: THERA TOUCH EX4 CLINICAL STIM 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: 24467905
• Report Number: 3005170249-2026-00002
• Device Sequence Number: 10230352
• Product Code: GZJ
• UDI-Device Identifier: 00092237621479
• UDI-Public: 00092237621479
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: DQ7200 (MANUFACTURER# MT2400)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 48 KG