MAUDE Adverse Event Report: SYRTENTY / SHAOXING DL HEALTHCARE CO., LTD. SYRTENTY TENS ELECTRODE PADS 1"; ELECTRODE, CUTANEOUS

Model Number B00K504ED4 TSYR1000

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Itching Sensation (1943); Rash (2033); Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545)

Event Date 12/22/2021

Event Type  Injury  

Event Description

Rash presumably from contact dermatitis to over-the-counter tens electrodes.A research study participant in a study involving an over-the-counter tens unit described itching under the tens electrode pads on (b)(6) 2021.During a phone call check-in on (b)(6) 2021, the participant reported some skin irritation and open sore at the electrode pad sites.He used hydrocortisone cream and moved the electrodes from the location of the skin irritation.Study staff communicated the information to the pi.Research study participation began (b)(6) 2021 and ended 4 weeks later on (b)(6) 2022.On (b)(6) 2022 he communicated with a colleague of ours at another institution who had published similar work, that while the mns tens unit did wonders for him, after several weeks of daily use his skin became irritated by the gel pads.He developed breakouts on his skin and the stinging led to some "burns" that took about 4 weeks to heal.On (b)(6) 2022, the external colleague emailed dr.(b)(6) to notify him of the participant's rash.Study staff contacted the participant by phone on (b)(6) 2022, when he described the rash in more detail, explaining that when the tens unit was on, there was itching and slight stinging on the skin where the pads were placed.A rash developed where the pads were placed on the skin.The rash had tiny bumps that broke and the skin looked mildly inflamed.He stopped placing the pads on the site of the rash and used hydrocortisone cream on it.After 4-6 weeks the rash had gone away.A (b)(6) call was scheduled for the participant to follow up with the study pi on (b)(6) 2022.Further details from that call: after about a week, he had occasional mild itching at the location of the electrode pads when they were on the skin.He endorses rubbing it with the tips of his fingers, but not scratching with his nails.By 3 weeks, he started to notice itching at the site.After a further period of time, the area developed small "pimples" (red papules), always only under the pads.Then they broke open (clear, colorless fluid).He kept the skin clean.When there was a broken-open lesion, "the electrical current burned / prickled like crazy." he switched the stimulation to the other forearm, and shortly it started up again.Kept pads off for 4-5 weeks before it healed completely.Fully healed at present.Two days ago, he scraped all the sticky gel off the carbon fiber electrode side of the tens pads and further wiped the electrode with alcohol to remove any remaining adhesive.He initially added spectra 360 electrode gel he had bought online, but it started itching within an hour or so, so he took them off.Since yesterday, he's using the device without the gel, with hydrocortisone lotion, and has no skin symptoms.Note: https://pubmed.Ncbi.Nlm.Nih.Gov/15235538/ describes contact dermatitis from polyacrylate in a tens electrode, and this participant's symptoms sound consistent with that.(that report also mentions previous reports of dermatitis from nickel electrodes or wires or from latex rubber electrode pads, neither of which pertain to the pads we're using for this study.) fda safety report id #:(b)(4).

• Brand Name: SYRTENTY TENS ELECTRODE PADS 1"
• Type of Device: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): SYRTENTY / SHAOXING DL HEALTHCARE CO., LTD.
• MDR Report Key: 13603438
• MDR Text Key: 286447499
• Report Number: MW5107729
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: B00K504ED4 TSYR1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White