inforMED
MalfunctionNUH

AUVON

Received Dec 2, 2025 · Event occurred May 24, 2025

Report 3013957847-2025-00001 · MDR key 23690617

Device

Generic name

Tens & Ems Device

Model number

TP2208

Product problems

  • Tear, Rip or Hole in Device Packaging
  • Tear, Rip or Hole in Device Packaging

Patient

45 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THIS DEVICE HAS NOT BEEN USED BY THE CUSTOMER YET AND NO ADVERSE INJURIES OR MALFUNCTIONS HAVE OCCURRED. THE CUSTOMER REPORTED THAT THE EQUIPMENT HAD OBVIOUS USAGE MARKS AND LACKED A USB CHARGING CABLE. SINCE THE EQUIPMENT WAS DIRECTLY RETURNED TO AMAZON, IT WAS NOT RETURNED TO THE DISTRIBUTOR OR MANUFACTURER FOR ANALYSIS, THE BATCH NUMBER INFORMATION OF THE DEVICE CANNOT BE OBTAINED. BASED ON THE CUSTOMER FEEDBACK REGARDING THE PURCHASE TIME AND DELIVERY TIME, WE HAVE CHECKED THE PRODUCT QUALITY INSPECTION AND ACCEPTANCE FORM FOR THE RELEVANT ORDERS DURING THIS PERIOD (AS SHOWN IN THE ATTACHMENT 1). THE SECOND ITEM: "PACKAGING AND ACCESSORY INSPECTION", "THE TYPES AND QUANTITIES OF ACCESSORIES ARE CONSISTENT WITH THE SAMPLES, CHARGING CABLE * 1, SOLDERING PADS * 6, CONNECTING CABLE * 2, MAIN UNIT * 1, MANUAL * 2", AND THE INSPECTION RESULTS FOR ALL ITEMS WERE ALL QUALIFIED. WE ALSO QUERIED THE PAST DATA OF SIMILAR ADVERSE EVENTS OF THE COMPANY'S SIMILAR PRODUCTS, BUT FOUND NO SIMILAR INCIDENTS. BASED ON THE PHOTOS AND DESCRIPTION PROVIDED BY THE CUSTOMER WHEN OPENING THE BOX, IT IS SPECULATED THAT AMAZON RE-SOLD A RETURNED PRODUCT FROM ANOTHER CUSTOMER AS A NEW ONE TO THIS CUSTOMER. WHEN THE INCIDENT OCCURRED, A NEW PRODUCT WAS PROMPTLY EXCHANGED FOR THE CUSTOMER. SINCE AMAZON'S RETURN ASSESSMENT IS EITHER SALEABLE OR NON-SALEABLE AND IS NOT CONTROLLED BY THE DISTRIBUTOR OR MANUFACTURER, WE WILL DEACTIVATE THE SECONDARY SALE MECHANISM FOR THIS PRODUCT (AS SHOWN IN ATTACHMENT 2) TO PREVENT SIMILAR INCIDENTS FROM OCCURRING AGAIN.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY PURCHASED AN AUVON TENS & EMS MEDICAL DEVICE FROM AMAZON. 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 RECEIVING IT. THE CUSTOMER CALLED AMAZON TO COMPLAIN ABOUT THE CONDITION OF THE DEVICE, AND AMAZON PROCESSED A RETURN FOR THEM.

Remedial action

  • Replace