BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETITE PLUS

    MDR report key: 340303 · Received June 29, 2001

    Report

    Report Number
    1416900-2001-00045
    Event Type
    Malfunction
    Date Received
    June 29, 2001
    Date of Event
    May 1, 2001
    Report Date
    June 22, 2001
    Manufacturer
    BELTONE ELECTRONICS CRP.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) DISPENSER REPORTED THAT THE SENTRY 2 WAX GUARD CAME UNSEATED FROM THE HEARING AID AND FELL INTO THE USER'S EAR CANAL. THE WAX GUARD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29487 PETITE PLUS HEARING AID ESD BELTONE ELECTRONICS CRP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention