BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISA

    MDR report key: 349738 · Received August 24, 2001

    Report

    Report Number
    1416900-2001-00056
    Event Type
    Malfunction
    Date Received
    August 24, 2001
    Date of Event
    July 1, 2001
    Report Date
    August 17, 2001
    Manufacturer
    BELTONE ELECTRONICS CRP.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 AND FELL INTO THE USER'S EAR CANAL. THE HEARING AID USER WAS REFERRED TO A PHYSICIAN WHO REMOVED THE WAX GUARD. NO INJURY TO THE USER'S EAR WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38716 INVISA HEARING AID ESD BELTONE ELECTRONICS CRP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention