MAUDE Adverse Event Report: COCHLEAR BAHA; HEARING AID, BONE CONDUCTION

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The t-coil does not come with the baha implant device, making it difficult for the patient to use a land line phone.

• Brand Name: BAHA
• Type of Device: HEARING AID, BONE CONDUCTION
• Manufacturer (Section D): COCHLEAR
• MDR Report Key: 7295803
• MDR Text Key: 101118831
• Report Number: MW5075484
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 90 YR
• Patient Weight: 77