BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS RIC HEARING AIDS AND DERIVATIVES

    MDR report key: 3619473 · Received November 19, 2013

    Report

    Report Number
    3005019184-2013-00007
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    September 23, 2013
    Report Date
    November 19, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE U.S. USER GUIDE FOR THE RECEIVER-IN-CANAL PRODUCT EQUIVALENT TO THE PRODUCT IN THE (B)(6) 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. SIMILAR PARTS WERE RETURNED TO SIEMENS AUDIOLOGISCHE TECHNIK (SAT) IN (B)(4) FOR ANALYSIS. NO OBVIOUS FAILURES DETECTED. 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. THIS REPORT WAS FILED LATE BECAUSE DESIGNATES COMPLAINT HANDLING UNIT AT SAT IN (B)(4) WAS UNAWARE OF DETAILS OF THE INCIDENT THAT WOULD HAVE INDICATED THAT THE EVENT MAY BE MDR REPORTABLE. THE AWARENESS DATE AT THE EVENT MAY BE MDR REPORTABLE. THE AWARENESS DATE AT THE (B)(4) AFFILIATE WAS (B)(4) 2013, BUT SAT WAS NOT INFORMED OF THE DETAILS OF THE EVENT UNTIL (B)(4) 2013. THEREFORE A CAPA (B)(4) WAS OPENED TO GUARANTEE THAT IN FUTURE ALL NECESSARY INCIDENT INFORMATION WITHIN THE INTERNATIONAL HEALTHCARE AUDIOLOGY (HAU) ORGANIZATION WILL BE PROVIDED IN THE REQUIRED TIME PERIOD AND COMMUNICATED AS INDICATED TO ALL AFFECTED COMPETENT AUTHORITIES.

    Description of Event or Problem · 1

    (B)(6) 2013: PATIENT IN (B)(6) VISITED HEARING HEALTH PROFESSIONAL AND STATED SHE HAD STRONG PAIN IN HER RIGHT EAR. OTOSCOPIC EXAMINATION FOUND A SILICON DOME IN THE EAR. HEARING HEALTH PROFESSIONAL ACCOMPANIED PATIENT TO THE DOCTOR. THE DOCTOR DIAGNOSED ACUTE INFLAMMATION AND WAS NOT ABLE TO REMOVE THE DOME. THE DOCTOR DECIDED THAT THE PATIENT SHOULD BE ADMITTED TO THE LARYNGOLOGICAL WARD AT THE (B)(6) HOSPITAL. THE DOCTOR PRESCRIBED ANTIBIOTICS. (B)(6) 2013: THE PATIENT WAS ADMITTED TO LARYNGOLOGICAL WARD IN HOSPITAL. THE DOME WAS REMOVED WITHOUT SURGERY. THE PATIENT WAS DISCHARGED WITH PRESCRIBED ANTIBIOTICS. (B)(6) 2013: CONSULTATION AT THE DOCTOR. THE EXAMINATION REVEALED THAT NO DAMAGE WAS CAUSED TO THE EAR AND THE HEALING PROGRESS WAS AS EXPECTED. THE HEARING HEALTH PROFESSIONAL ACCOMPANIED THE PATIENT ON THE DOCTOR VISIT. (B)(6) 2013: FOLLOW-UP HEARING EXAMINATION AT HEARING HEALTH PROFESSIONAL CONFIRMED NO DETERIORATION IN HEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600855 SIEMENS RIC HEARING AIDS AND DERIVATIVES RECEIVER-IN-CANAL HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC. CLICK DOME 8MM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention