BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA 2000

    MDR report key: 349733 · Received August 24, 2001

    Report

    Report Number
    1416900-2001-00057
    Event Type
    Malfunction
    Date Received
    August 24, 2001
    Date of Event
    July 1, 2001
    Report Date
    August 20, 2001
    Manufacturer
    BELTONE ELECTRONICS CRP.
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HEARING AID (H/A) DISPENSER REPORTED THAT THE FLEX TIP OPTION HAD COME DETACHED FROM THE HEARING AID SHELL AND REMAINED IN THE USER'S EAR CANAL. A PHYSICIAN REMOVED THE FLEX TIP FROM THE USER'S EAR CANAL. THERE WAS NO EVIDENCE OF INJURY TO THE USER'S EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39213 OPTIMA 2000 HEARING AID ESD BELTONE ELECTRONICS CRP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention