MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. COMPASS HEALTH BRANDS; TENS 7000 DIGITAL

Model Number	DT7202(MANUFACTURER# TENS 7000)
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Electric Shock (2554)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was also reported to fda by the importer under importer report no.3012316249-2024-00016.We checked the other batch of dhr (device history records) since no serial number was provided and there were no abnormal test results 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.Additional reporting on this event will be provided as a supplemental report to this document if more information becomes available.
Event or Problem Description
Affected products: b00ncre4go - tens 7000 digital tens unit with accessories - tens unit muscle stimulator for back pain.Relief, shoulder pain relief, neck pain, sciatica pain relief, nerve pain relief asin variations: na.Customer feedback: (b)(6) 2024: "does not stimulate.Shocks.Caused me to go into cardiac arrest.".

• Brand Name: COMPASS HEALTH BRANDS
• Common Device Name: TENS 7000 DIGITAL
• 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: 24468313
• Report Number: 3005170249-2026-00001
• Device Sequence Number: 9615765
• Product Code: NUH
• UDI-Device Identifier: 00092237616796
• UDI-Public: 00092237616796
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130802
• 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
• 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
• Device Model Number: DT7202(MANUFACTURER# TENS 7000)
• 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 Sex: Unknown