COMPASS HEALTH BRANDS
Received Feb 27, 2026
Report 3005170249-2026-00001 · MDR key 24468313
Device
Generic name
Tens 7000 Digital
Manufacturer
Shenzhen Dongdixin Technology Co., Ltd.Model number
DT7202(MANUFACTURER# TENS 7000)Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- Electric Shock
Narrative
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.
Description of Event or Problem
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."