inforMED
InjuryDRX

NISSHA MEDICAL TECHNOLOGIES

Received Jul 22, 2026

Report 1317188-2026-00089 · MDR key 25906101

Device

Generic name

Ecg Monitoring Electrodes

Model number

A10091-30

Catalog number

32028476

Lot number

UNKNOWN

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Hypersensitivity/Allergic reaction
  • Skin Inflammation/ Irritation

Narrative

Additional Manufacturer Narrative

NO LOT NUMBER WAS PROVIDED, THEREFORE UNABLE TO CONFIRM IF THIS REPORT IS RELATED TO NISSHA PRODUCT, HOWEVER REPORTING OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem

THE PATIENT REPORTED EXPERIENCING AN ALLERGIC REACTION, BLEEDING/DISCHARGE, AND OPEN SORES. MEDICAL TREATMENT WAS SOUGHT AND THE PATIENT WAS TREATED WITH A PRESCRIPTION TOPICAL ANTI-INFLAMMATORY MEDICATION. THE PATIENT REPORTED FOLLOWING THE RECOMMENDED SKIN PREPARATION STEPS.