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

Model Number DT7303

Device Problem Human-Device Interface Problem (2949)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/08/2023

Event Type  Injury  

Event 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.

• Brand Name: COMPASS HEALTH BRANDS
• Type of Device: TENS 7000 RECHARGEABLE
• Manufacturer (Section D): HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED; 2f, yongcheng blvd, xicheng in; xixiang street, bao'an distric; shenzhen guangdong, cn 51812 6; CH 518126
• MDR Report Key: 17031655
• MDR Text Key: 316284395
• Report Number: 3012316249-2023-00013
• Device Sequence Number: 1
• Product Code: GYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2023

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 Operator: Lay User/Patient
• Device Model Number: DT7303
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2023
• Distributor Facility Aware Date: 05/09/2023
• Device Age: 8 MO
• Event Location: Home
• Date Report to Manufacturer: 05/31/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 74 KG