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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994)

Event Date 09/17/2020

Event Type  Injury  

Event 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
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
• Manufacturer (Section D): SHENZHEN HUAYAN E-COMMERCE CO.,/SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
• MDR Report Key: 10976020
• MDR Text Key: 220753942
• Report Number: MW5098271
• Device Sequence Number: 1
• Product Code: GZJ
• UDI-Device Identifier: 00321908130133
• UDI-Public: 0100321908130133
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SM9126
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 88