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

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).

• Brand Name: AUVON DUAL CHANNEL TENS UNIT MUSCLE STIMULATOR MACHINE WITH 20 MODES
• Type of Device: STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER
• Manufacturer (Section D): SHENZHEN YUWEN E-COMMERCE CO.,/ SHEN ZHEN AS TEC TECHNOLOGY CO LTD
• MDR Report Key: 11154437
• MDR Text Key: 226648512
• Report Number: MW5098765
• Device Sequence Number: 1
• Product Code: NUH
• Combination Product (y/n): Y
• Number of Events Reported: 1
• 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 Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AS8012
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 58 YR