OTOCLEAR
Received Mar 10, 2015 · Event occurred Sep 22, 2014
Report 4616565 · MDR key 4616565
Device
Generic name
Ear Irrigation System
Manufacturer
Bionix Development Corp.Model number
7280Catalog number
*
Lot number
120515GAJ
Product problems
- Decrease in Pressure
Patient
62 YR
- Pain
Narrative
Description of Event or Problem
PATIENT REPORTED TO THE ORGANIZATION THE EXPERIENCE OF FEELING INCREASED PRESSURE DURING THE IRRIGATION PROCEDURE AND THEN INCREASED EAR PAIN THE MORNING. REVIEW CONFIRMED THAT THE MEDICAL ASSISTANT UTILIZED LOW PRESSURE CONSISTENTLY AND ONLY ADJUSTED THE TEMPERATURE DURING THE PROCEDURE.