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

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

Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 02/03/2020

Event Type  Injury  

Event 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
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): SHENZHEN HUAYAN E-COMMERCE / HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
• MDR Report Key: 11019252
• MDR Text Key: 222091573
• Report Number: MW5098402
• Device Sequence Number: 1
• Product Code: NUH
• UDI-Device Identifier: 00321911080036
• UDI-Public: 00321911080036
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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): Disability
• Patient Age: 69 YR
• Patient Weight: 92