BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISA

    MDR report key: 334615 · Received May 21, 2001

    Report

    Report Number
    1416900-2001-00033
    Event Type
    Malfunction
    Date Received
    May 21, 2001
    Date of Event
    March 1, 2001
    Report Date
    May 17, 2001
    Manufacturer
    BELTONE ELECTRONICS CRP.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) DISPENSER REPORTED THAT THE SENTRY 2 WAXGUARD CAME UNSEATED FROM THE HEARING AID AND FELL INTO THE USER'S EAR CANAL. THE WAXGUARD WAS REMOVED WITHOUT INJURY TO THE USER'S EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23731 INVISA HEARING AID ESD BELTONE ELECTRONICS CRP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention