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U.S. Department of Health and Human Services

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

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COCHLEAR BAHA HEARING AID, BONE CONDUCTION Back to Search Results
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.

 
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Brand NameBAHA
Type of DeviceHEARING AID, BONE CONDUCTION
Manufacturer (Section D)
COCHLEAR
MDR Report Key7295803
MDR Text Key101118831
Report NumberMW5075484
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/23/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
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

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