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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN YUWEN E-COMMERCE CO.,/ SHEN ZHEN AS TEC TECHNOLOGY CO LTD AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE WITH 20 MODES STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

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SHENZHEN YUWEN E-COMMERCE CO.,/ SHEN ZHEN AS TEC TECHNOLOGY CO LTD AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE WITH 20 MODES STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
Model Number AS8012
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Burn, Thermal (2530)
Event Date 12/30/2020
Event Type  Injury  
Event Description
Burn(s); erythema; itching, it is a tens product. Model no. As8012. Bought on (b)(6) for traps and neck pain. Used once on a friday and woke up saturday with skin petechiae/electrical burns on left hand and forearm. The brand name is (b)(6). The product link is (b)(6) the seller name is: (b)(4). Manufacturer is: shenzhen as-tec technology co. , ltd. Fda safety report id #: (b)(4).
 
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Brand NameAUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE WITH 20 MODES
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Manufacturer (Section D)
SHENZHEN YUWEN E-COMMERCE CO.,/ SHEN ZHEN AS TEC TECHNOLOGY CO LTD
MDR Report Key11154437
MDR Text Key226648512
Report NumberMW5098765
Device Sequence Number1
Product Code NUH
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAS8012
Was Device Available for Evaluation? No
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: 01/11/2021 Patient Sequence Number: 1
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