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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN AS-TEC TECHNOLOGY CO LTD AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER

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SHENZHEN AS-TEC TECHNOLOGY CO LTD AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER Back to Search Results
Model Number AS8012
Device Problem Excessive Heating (4030)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Burn, Thermal (2530)
Event Date 01/10/2021
Event Type  Injury  
Event Description
Product name is auvon dual channel tens unit muscle stimulator machine? model no. As8012; i bought it on (b)(6), the link is: (b)(6) problem: i got a sharp pain when i am using the tens unit and saw the pads left mild burns on my skin. It is like allergy symptoms and the skin was itching and redness for several days and recovered if i stopped using it. But if i restart using it, it left burns on the skins again. Company name is shenzhen yuwen e-commerce co. , ltd. Manufacturer: 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
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
Manufacturer (Section D)
SHENZHEN AS-TEC TECHNOLOGY CO LTD
MDR Report Key11170158
MDR Text Key227477597
Report NumberMW5098822
Device Sequence Number1
Product Code NUH
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAS8012
Device Catalogue NumberAUAS20200824001
Device Lot NumberAUAS20200824001
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: 01/13/2021 Patient Sequence Number: 1
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