BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRA ACTIVE

    MDR report key: 3766015 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00009
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    March 16, 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 MDR REPORTABLE. A RETROSPECTIVE REVIEW OF COMPLAINTS, HOWEVER IDENTIFIED THIS INCIDENT AS MDR REPORTABLE. 2007 INVESTIGATION AND CONCLUSION: INCORRECT GLUING BETWEEN THE SPOUT AND THE RECEIVER. PULL FORCE TEST IMPLEMENTED AT PRODUCTION. RISK ASSESSMENT: THE CENTRA ACTIVE USER GUIDE DESCRIBES THE CORRECT FITTING OF THE DOME. IT STATES THAT IF THE DOME REMAINS IN THE EAR, IT SHOULD BE REMOVED BY A MEDICAL PROFESSIONAL. THE SEPARATION OF THE DOME FORM THE HEARING DEVICE TO REMAIN IN THE EAR CANAL WAS CONSIDERED A VERY LOW HEALTH RISK BECAUSE THE DOME CAN BE REMOVED BY A MEDICAL PROFESSIONAL WITHOUT PRESENTING A HEALTH HAZARD TO THE PATIENT. DETACHED SMALL PARTS REMAINING IN THE EAR CANAL GENERALLY PRESENT NO HEALTH HAZARD FOR THE HEARING AID USER. AN IMPROVED HOME DESIGN WITH METAL RING WAS IMPLEMENTED TO IMPROVE THE RETENTION OF THE C-GUARD IN THE DOME. 2013 UPDATE: THE U.S. USER GUIDE FOR THE RECEIVER-IN-CANAL PRODUCT EQUIVALENT TO THE PRODUCT IN THE INCIDENT DESCRIBES THE CORRECT FITTING OF THE DOME. THERE IS A WARNING THAT IF THE DOME BECOMES DETACHED IN THE PATIENT'S EAR, THE PATIENT SHOULD CONTACT THEIR AUDIOLOGIST OR HEARING CARE PROFESSIONAL OR PHYSICIAN IMMEDIATELY. THE SAFETY BOARD CONCLUDED NO FURTHER ACTIONS WERE NECESSARY. THE SEPARATION OF THE DOME FROM THE HEARING DEVICE TO REMAIN IN THE EAR CANAL IS CONSIDERED A VERY LOW HEALTH RISK BECAUSE THE DOME CAN BE REMOVED BY A MEDICAL PROFESSIONAL WITHOUT PRESENTING A HEALTH HAZARD TO THE PATIENT.

    Description of Event or Problem · 1

    A PATIENT IN THE (B)(6) USING CENTRA ACTIVE HEARING AID FIT WITH A DOME CONTAINING A WAX GUARD (C-GUARD) HAD TO GO TO THE DOCTOR TO GET A DOME REMOVED OUT OF HIS EAR. THE DOCTOR REMOVED THE DOME WITHOUT INJURING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667502 CENTRA ACTIVE BEHIND THE EAR HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1