MAUDE Adverse Event Report: SHENZHEN HUAYAN E-COMMERCE CO.,/SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED BELIFU DUAL CHANNEL TENS EMS UNIT 24 MODES MUSCLE STIMULATOR FOR PAIN RELIEF THE; STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Model Number	SM9126
Health Effect - Clinical Codes	Burn(s) (1757); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
I got a sharp pain when i am using the tens unit and saw the pads left mild burns on my skin.It is like allergy symptoms and the skin was itching and redness for several days and recovered if i stopped using it.But if i restart using it, it left burns on the skins again.Fda safety report id # (b)(4).

• Brand Name: BELIFU DUAL CHANNEL TENS EMS UNIT 24 MODES MUSCLE STIMULATOR FOR PAIN RELIEF THE
• Common Device Name: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): SHENZHEN HUAYAN E-COMMERCE CO.,/SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
• MDR Report Key: 10976020
• Report Number: MW5098271
• Device Sequence Number: 10919970
• Product Code: GZJ
• UDI-Device Identifier: 00321908130133
• UDI-Public: 0100321908130133
• Initial Reporter State: GA
• 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): 12/06/2020

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
• Device Model Number: SM9126
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 88