MAUDE Adverse Event Report: KIRKLAND/PHONAK/ SONOVA AG KIRKLAND SIGNATURE 10.0 HEARING AID WITH TCOIL PREMIUM DIGITAL RECHARGEABLE HEAR HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number ITEM #1541000

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/15/2021

Event Type  Injury  

Event Description

(b)(6) 10. 0 hearing aid. Has a plastic cover over the hearing aid called an "earpiece. " this earpiece is now stuck in my ear. I'm not sure why it separated from the hearing aid but (b)(6) has advised me to go to an urgent care to have it removed or come to (b)(6) to have it removed or replaced. This hearing aid may need a product recall because of this potential failure. Fda safety report id # (b)(4).

• Brand Name: KIRKLAND SIGNATURE 10.0 HEARING AID WITH TCOIL PREMIUM DIGITAL RECHARGEABLE HEAR
• Type of Device: HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): KIRKLAND/PHONAK/ SONOVA AG
• MDR Report Key: 12032270
• MDR Text Key: 257405293
• Report Number: MW5101977
• Device Sequence Number: 1
• Product Code: OSM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ITEM #1541000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 06/17/2021 Patient Sequence Number: 1