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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BAHA/ ATTRACT HEARING IMPLANT

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COCHLEAR BAHA/ ATTRACT HEARING IMPLANT Back to Search Results
Device Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/10/2014
Event Type  Malfunction  
Event Description

I have a baha (bone anchored hearing aid). This device is surgically implanted in the skull and has a magnet under the scalp. The "safety card" that i carry i supposed to provide information on mri's. The mri has to be set at certain settings or i could be seriously injured and or suffer fatal injuries. The card supplied is terrible and i've complained by e-mail to the company, cochlear, several times to no avail. They are headquartered in (b)(4) but have a facility in (b)(4). I'm concerned that if i were in an emergency situation and unable to tell medical facility about the magnet, there is absolutely no way anyone would give this card a second look. Is there anything your agency can do to remedy this?.

 
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Brand NameBAHA/ ATTRACT
Type of DeviceHEARING IMPLANT
Manufacturer (Section D)
COCHLEAR
MDR Report Key6145223
MDR Text Key61517799
Report NumberMW5066526
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 12/02/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/02/2016
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
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? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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