MAUDE Adverse Event Report: HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED COMPASS HEALTH BRANDS; TENS 7000 RECHARGEABLE

Model Number	DT7303
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer said he has burn/black marks where the electrodes were on his body.No doctor approval was received as this was an otc device and previous burns is not listed as a contraindication.Customer said i have used previous electrodes and tens units without issue.Per twf: pre-existing conditions is "previous burns, healed, at area".Biphasic rectangular, modulated waveform - 100 hz @ 300 s pulse width using 2x2" self adhesive electrodes on left upper arm 5" apart, 2 in total.When asked if new or used, customer states "yes".States burns appeared immediately, removed due to sensation of burns, on going.He did seek medical attention.States electrodes used "0" times previously.States electrodes stored in the original packaging between 41-86f and 40-70% humidity.Room air.States electrodes were.5" apart, no known allergies.300us width, 100hz rate.Using tens 7000 brand electrodes.Has not tried new leads, show no damage.The original burns were caused by a house fire in 2013.The tissue, at time of use, was healed and has been for ~ 7 years.2.Were the electrodes 5" apart or.5"? 0.5." 3.Were the electrodes 100% adhered to the skin when you were using them? yes.User manual attached: page19, bottom of page warning: to avoid an electrical short, never put two electrode pads together.They must be at least 2" but not more than 6" apart.
Additional Manufacturer Narrative
Investigation of the cause: after inquiring with the distributor, it was learned that a user had a burn on their skin in the past, which had healed many years ago.When using the product in accordance with the instructions, they felt a burning sensation and stopped using it.No injury was caused.The user had consulted the us distributor.After investigation: 1.The product verification report was checked.This model of product has passed the iec60601-2-10:2016 standard test (report no.: (b)(4), report date: 2023-02-10), and the output energy of the product meets safety requirements.2.The production batch record of order (b)(4) (n0: (b)(4)) was checked.This batch of production complies with product specification requirements.3.The product design and production both meet the standards and quality requirements.Regarding the reminder of discomfort during use, it has been mentioned in the tens 7000 rechargeable user manual v1.1.4.As the user's injured area had healed for many years, they were not aware that the healed skin was more sensitive than normal skin.Therefore, they used the product without consulting a doctor.5.No such problem reports have been received for this product in previous sales.Action: 1.Since the product design meets the standard requirements and the production complies with the specification requirements, no capa is necessary.2.The marketing department will contact the distributors, asking them to contact the user for an explanation.They should inform the user that the skin that has healed from an injury is sensitive and is not suitable for using the tens product at this location.

• Brand Name: COMPASS HEALTH BRANDS
• Common Device Name: TENS 7000 RECHARGEABLE
• Manufacturer (Section D): HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED; 2f, yongcheng blvd,; xicheng industrial zone; shenzhen, bao'an district, guangdong 51812 6; CH 518126
• Manufacturer (Section G): HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED; 2f, yongcheng blvd,; xicheng industrial zone; shenzhen, bao'an district, guangdong 51812 6; CH 518126
• Manufacturer Contact: ms hera ; 2f, yongcheng blvd,; xicheng industrial zone; shenzhen, bao'an district, guangdong 51812-6 ; CH 518126
• MDR Report Key: 22693802
• Report Number: 3010402752-2025-00002
• Device Sequence Number: 21119656
• Product Code: GYB
• UDI-Device Identifier: 00092237623756
• UDI-Public: 00092237623756
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/01/2026
• Device Model Number: DT7303
• Device Lot Number: P026-220818155
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 08/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 74 KG