inforMED
MalfunctionEGJ

IONTO 4 IONTOPHORETIC STIMULATOR

Received Jan 3, 2025 · Event occurred Aug 14, 2024

Report 21066027 · MDR key 21066027

Device

Generic name

Device, Iontophoresis, Other Uses

Patient

54 YR · Female

  • Superficial (First Degree) Burn
  • Superficial (First Degree) Burn

Narrative

Description of Event or Problem

ON (DATE REDACTED), THE PATIENT UNDERWENT AN AUTONOMIC REFLEX TEST. TWO DAYS LATER, THE PATIENT REPORTED THAT SHE NOTICED A BURN MARK ON HER LEFT KNEE THE DAY AFTER THE TEST AND THOUGHT IT WAS POSSIBLY RELATED TO AN ELECTRODE. SHE EXPLAINED THAT THE ELECTRODE ATTACHED TO HER KNEE HAD BEEN ¿BURNING¿ DURING THE TEST. IT IS UNCLEAR IF THE AREA THAT THE PATIENT DESCRIBED AS A SMALL BURN, WAS ASSOCIATED WITH THE AUTONOMIC REFLEX TEST, AND STAFF DO NOT BELIEVE THE ELECTRODE HAD BEEN PLACED IN THIS AREA. HOWEVER, THIS IS NOTED AS A POTENTIAL SIDE EFFECT BY THE MANUFACTURER. DURING THE TEST, THE TECHNOLOGIST WAS NOT AWARE OF ANY COMPLAINT OF PAIN AND DID NOT OBSERVE ANY BLISTERS OR BURNS ON THE PATIENT AFTER THE TEST. THE DEPARTMENT CONFIRMED THAT THE EQUIPMENT WAS WORKING PROPERLY, AND HEALTHCARE TECHNOLOGY MANAGEMENT VERIFIED THAT THE EQUIPMENT PASSED ALL TESTS.