BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRA ACTIVE

    MDR report key: 3765993 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00008
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    March 13, 2007
    Report Date
    December 18, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC
    Product Code
    ESD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    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. A 2013 UPDATE: 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 PT.

    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 TO GO TO THE DOCTOR TO GET A DOME REMOVED OUT OF HIS EAR. THE DOCTOR REMOVED THE DOME WITHOUT INJURING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667029 CENTRA ACTIVE BEHIND THE EAR HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention