MAUDE Adverse Event Report: EARGO EARGO SYSTEM SIZE 12

Model Number 99-0001-001

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 10/05/2015

Event Type  Injury  

Event Description

The rubber tip on one of my eargo hearing devices separated from the body of the device and lodged deep within my ear canal (it moved further down because the foxtail-like design of it).The tip caused pain and discomfort until my doctor extracted it from my ear.

• Brand Name: EARGO SYSTEM SIZE 12
• Type of Device: EARGO SYSTEM SIZE 12
• Manufacturer (Section D): EARGO
• MDR Report Key: 5149488
• MDR Text Key: 28355181
• Report Number: MW5056964
• Device Sequence Number: 1
• Product Code: ESD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 99-0001-001
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 91