MAUDE Adverse Event Report: SHENZHEN HUAYAN E-COMMERCE / HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED BELIFU TENS UNIT; STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

Model Number	SM9126
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Used it for 10 minutes on my lower back only for the pads to become super itchy.Left red inflamed patches the exact size of the pads for 2 weeks.Since the swelling has went down there are dark almost "tanned" patches that seem like they will never go away.It's been over 2 months.Bought on (b)(6), the link was (b)(6).Fda safety report id # (b)(4).

• Brand Name: BELIFU TENS UNIT
• Common Device Name: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): SHENZHEN HUAYAN E-COMMERCE / HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
• MDR Report Key: 11019252
• Report Number: MW5098402
• Device Sequence Number: 1023723
• Product Code: NUH
• UDI-Device Identifier: 00321911080036
• UDI-Public: 00321911080036
• 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): 12/14/2020

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: 12/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 69 YR
• Patient Weight: 92