MAUDE Adverse Event Report: DOCTOR EASY MEDICAL PRODUCTS, LLC DOCTOR EASY MEDICAL PRODUCTS; EAR IRRIGATION KIT

Model Number EI

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2021

Event Type  malfunction  

Event Description

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.

• Brand Name: DOCTOR EASY MEDICAL PRODUCTS
• Type of Device: EAR IRRIGATION KIT
• Manufacturer (Section D): DOCTOR EASY MEDICAL PRODUCTS, LLC; 1029 blanding blvd. suite 701; orange park FL 32065
• MDR Report Key: 12370130
• MDR Text Key: 268248068
• Report Number: 12370130
• Device Sequence Number: 1
• Product Code: OGQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EI
• Device Catalogue Number: EI
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2021
• Event Location: Other
• Date Report to Manufacturer: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1