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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STARKEY LABORATORIES, INC. HEARING AID

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STARKEY LABORATORIES, INC. HEARING AID Back to Search Results
Model Number SOUNDSTEN 7
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Swelling (2091)
Event Date 10/16/2015
Event Type  Malfunction  
Event Description

Hearing aids cause soreness and swelling and hurt. Numerous adjustments have been made and the problems continue. Dates of use: (b)(6) 2015 - (b)(6) 2016. Diagnosis or reason for use: hearing loss. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.

 
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Brand NameHEARING AID
Type of DeviceHEARING AID
Manufacturer (Section D)
STARKEY LABORATORIES, INC.
MDR Report Key6629575
MDR Text Key77284656
Report NumberMW5070259
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 05/19/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberSOUNDSTEN 7
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/10/2016
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? No
Type of Device Usage

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