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

Model Number	DQ7200(MANUFACTURER# MT2400)
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have communicated with the importer, this equipment has not been returned to the importer, the equipment has not been returned for analysis.We checked the same batch of dhr (device history records) and there were no high strength or instantaneous strength increases recorded in the dhr during production or testing.The cause of the customer complaint could not be determined because the device was not returned for analysis.
Event or Problem Description
Customer called in because their device has burnt this patient.The lead wires and pads have since been changed.No doctor visit was necessary for the burn but blistering did occurr on the customer.
Additional Manufacturer Narrative
This event was also reported to fda by the importer under importer report no.(b)(4).(1) investigation and analysis methodology: a complaint investigation was initiated.Initially, the unit had not been returned for analysis and a same-batch dhr review did not identify high strength or instantaneous strength increases during production or testing.The unit was subsequently returned to the distributor/importer for evaluation.The importer reported that the complaint could not be duplicated and that if-4p output tested within specification for all channels and lead wires, while an apparent abnormal waveform/behavior was observed on high volt only.The unit was then returned to the manufacturer for further review.The manufacturer's evaluation confirmed the device output met specifications and concluded that the importer's apparent high volt waveform abnormality was attributable to incorrect oscilloscope settings during the importer's test (i.E., a test artifact).(2) specific failure mode(s)/mechanism(s) and associated component(s): a definitive device failure mode could not be confirmed.The reported injury occurred while using if-4p, and if-4p output tested within specification.The importer's high volt concern was not confirmed as a device condition and was determined by the manufacturer to be a measurement artifact related to oscilloscope configuration, not evidence of device malfunction.Given the clinical outcome and subsequent replacement of pads/leads, electrode-skin interface conditions and accessory integrity (pads/leads/connectors, contact quality, placement) remain considerations; however, causality cannot be established with the available information.(3) conclusions: the complaint could not be duplicated during evaluation.The manufacturer confirmed the unit output met specifications.The issue observed by the importer was attributable to oscilloscope settings rather than device malfunction.Root cause cannot be definitively determined with currently available information.The device will be retained and investigation/test records are maintained in the complaint file for traceability and fda inspection.

• Brand Name: ROSCOE
• Common Device Name: THERA TOUCH EX4
• 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: 21696263
• Report Number: 3005170249-2025-00002
• Device Sequence Number: 9282268
• Product Code: GZJ
• UDI-Device Identifier: 00092237621479
• UDI-Public: 00092237621479
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2022
• 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: 75 YR
• Patient Sex: Female