MAUDE Adverse Event Report: NEUROMD MEDICAL TECHNOLOGIES NEUROMD CORRECTIVE THERAPY DEVICE® FOR BACK PAIN; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Scar Tissue (2060); Blister (4537)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
One day, when i used the neuromd pad (https://getneuromd.Com/), i experienced immediate and severe skin redness.Within a few hours, i developed skin blistering, itching, and pain around my lower back area where the pad was applied.The healing process took two months, and i still have dry patches of skin and some scarring.I used the neuromd pads almost every day from (b)(6) 2023 until (b)(6) 2024, when the allergic reaction occurred quite suddenly.

• Brand Name: NEUROMD CORRECTIVE THERAPY DEVICE® FOR BACK PAIN
• Common Device Name: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): NEUROMD MEDICAL TECHNOLOGIES; 18201 collins ave 4309a; sunny isles beach FL 33160
• MDR Report Key: 21333931
• Report Number: MW5165765
• Device Sequence Number: 8034774
• Product Code: GZJ
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/02/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COSAMIN DS JOINT HEALTH (1500 MG GLUCOSAMINE HCL+1200 MG CHONDROITIN SULFATE).; INTERMITTENT USE OF MELOXICAM 7.5 MG/ONCE A DAY.; TURMERIC 1000 MG WITH BLACK PEPPER (KIRKLAND).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White