inforMED
MalfunctionOGQ

DOCTOR EASY MEDICAL PRODUCTS

Received Aug 26, 2021 · Event occurred Jul 21, 2021

Report 12370130 · MDR key 12370130

Device

Generic name

Ear Irrigation Kit

Model number

EI

Catalog number

EI

Product problems

  • Output Problem

Patient

Not reported

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

ELEPHANT EAR WASHER HAS MALFUNCTIONED 4 TIMES IN THE LAST MONTH. INSTEAD OF EXPRESSING WARM WATER INTO THE EAR CANAL, WE HAVE HAD 4 INSTANCES WHERE IT IS EXPRESSING AIR INSTEAD OF WATER.