BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRA ACTIVE

    MDR report key: 3766011 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00013
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    May 11, 2007
    Report Date
    December 18, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC
    Product Code
    ESD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED LATE BECAUSE THE INCIDENT WAS INCORRECTLY CLASSIFIED AS NOT SAFETY REPORTABLE CRITICALLY. A RETROSPECTIVE REVIEW OF COMPLAINTS, HOWEVER, IDENTIFIED THIS INCIDENT AS MDR REPORTABLE. A 2007 INVESTIGATION AND CONCLUSION: INCORRECT GLUING BETWEEN THE SPOUT AND THE RECEIVER. PULL FORCE TEST IMPLEMENTED AT PRODUCTION.

    Description of Event or Problem · 1

    A PT IN (B)(6) USING CENTRA ACTIVE HEARING AID FIT WITH A DOME CONTAINING A WAX GUARD (C-GUARD) HAD THE C-GUARD SEPARATED FROM THE DOME WHILE INSERTING INTO THE EXTENDED RECEIVER UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666983 CENTRA ACTIVE BEHIND THE EAR HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention