FDA Adverse Event Malfunction Summary report: N

AUVON PT1 PRO RECHARGEABLE TENS DEVICE

MDR report key: 22126309 · Received June 2, 2025

Report

Report Number
MW5170962
Event Type
Malfunction
Date Received
June 2, 2025
Date of Event
May 24, 2025
Report Date
May 25, 2025
Manufacturer
SHENZHEN YUWEN E-COMMERCE CO., LTD.
Product Code
NUH
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
UNKNOWN
Health Professional
*

Narratives

Description of Event or Problem · 0

I PURCHASED AN AUVON TENS & EMS MEDICAL DEVICE FROM AMAZON (HTTPS://WWW.AMAZON.COM/GP/AW/D/B0CY2RCSCB). THE MODEL IS LISTED AS "AUVON PT1 PRO TENS UNIT". THE DEVICE ARRIVED AND SHOWED CLEAR SIGNS OF USE. IN PARTICULAR, 4 OF THE 6 ADHESIVE GEL PAD SKIN CONTACT ELECTRODES HAD CLEARLY BEEN REMOVED AND REPLACED ONTO THEIR BACKING (AIR BUBBLES AND MISALIGNMENT TO THE OUTLINE FROM THE ORIGINAL CUT MARKS), AND WERE NOT IN THE ORIGINAL WRAPPERS. ONE OF THE ELECTRODES ALSO HAD A VISIBLE WHITE WIRE UNUSUALLY ROUTED BELOW THE EXPOSED GEL SURFACE. THE ELECTRICAL WIRES HAD BEEN UNBUNDLED, AND THE USB CHARGING CABLE WAS ENTIRELY MISSING FROM THE PACKAGE. THE PRINTED MANUAL SHOWED SIGNS OF WATER EXPOSURE (SLIGHTLY WRINKLED). THE DEVICE WAS SOLD AS NEW VIA AMAZON, BUT HAD CLEARLY BEEN USED PRIOR TO ME RECEIVING IT. I CALLED AMAZON TO COMPLAIN ABOUT THE CONDITION OF THE DEVICE, AND THEY HAVE ASKED FOR IT TO BE RETURNED. MANY OTHER REVIEWS ON THE PRODUCT INDICATE USED EQUIPMENT BEING SHIPPED TO CUSTOMERS AS NEW DEVICES. THE PRODUCT PAGE IS: HTTPS://WWW.AMAZON.COM/GP/AW/D/B0CY2RCSCB AUVON RECHARGEABLE DIGITAL TENS UNIT MUSCLE STIMULATOR WITH 600 MAH BATTERY, TENS MACHINE WITH 8 CUSTOMIZABLE MODES, ELECTRIC MASSAGER FOR SHOULDER, BACK PAIN RELIEF, 6 TENS PADS, A CARRY CASE THE SELLER INFORMATION IS: HTTPS://WWW.AMAZON.COM/SP?IE=UTF8&SELLER=ABIY41HTAB3PA&ASIN=B0CY2RCSCB BUSINESS NAME: SHENZHEN YUWEN E-COMMERCE CO., LTD. BUSINESS ADDRESS: ????????153? ?????7?703 ??? ???? ??? 518109 CN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1065223 AUVON PT1 PRO RECHARGEABLE TENS DEVICE STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER NUH SHENZHEN YUWEN E-COMMERCE CO., LTD.

Patients

Seq Age Sex Outcome Treatment
1 45 YR Male