MAUDE Adverse Event Report: SHENZHEN HONGQIANGXING / 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	TENS
Health Effect - Clinical Codes	Skin Inflammation (2443); Burn, Thermal (2530)
Date of Event	04/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It is a tens product.Bought on (b)(6) for traps and neck pain.Used once on a friday and woke up saturday with skin petechia/electrical burns on left hand and forearm.The product link is (b)(6).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 HONGQIANGXING / SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED
• MDR Report Key: 10991679
• Report Number: MW5098317
• Device Sequence Number: 11413709
• Product Code: GZJ
• UDI-Device Identifier: 00321911080500
• UDI-Public: 00321911080500
• 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): 12/08/2020

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: TENS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Weight: 68