BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARING AID

    MDR report key: 6629575 · Received June 7, 2017

    Report

    Report Number
    MW5070259
    Event Type
    Malfunction
    Date Received
    June 7, 2017
    Date of Event
    October 16, 2015
    Report Date
    May 19, 2017
    Manufacturer
    STARKEY LABORATORIES, INC.
    Product Code
    LXB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398074 HEARING AID HEARING AID LXB STARKEY LABORATORIES, INC. SOUNDSTEN 7
    398075 HEARING AID HEARING AID LXB STARKEY LABORATORIES, INC. SOUNDSTEN 7

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR