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U.S. Department of Health and Human Services

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

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SHENZHEN HUAYAN E-COMMERCE / HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED BELIFU TENS UNIT STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
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).
 
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Brand NameBELIFU TENS UNIT
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Manufacturer (Section D)
SHENZHEN HUAYAN E-COMMERCE / HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
MDR Report Key11019252
MDR Text Key222091573
Report NumberMW5098402
Device Sequence Number1
Product Code NUH
Reporter Country CodeUS
Number of Events Reported1
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 Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSM9126
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/15/2020 Patient Sequence Number: 1
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