BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELTONE

    MDR report key: 10458790 · Received August 27, 2020

    Report

    Report Number
    3005650109-2020-00029
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 27, 2020
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05704819291462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GLOBAL AUDIOLOGY DEVELOPMENT: THE CASE HAS BEEN REVIEWED FROM A CLINICAL PERSPECTIVE. CUSTOMER REPORTED: THE END USER HAS EXPERIENCED A SKIN IRRITATION. SYMPTOMS APPEARED WITHIN THE FIRST WEEKS, AND LASTED FOR THE TIME THE DEVICES WERE WORN. SYMPTOMS STOPPED WHEN END USER STOPPED WEARING THE HEARING AIDS. THE REACTION HAS BEEN CONFIRMED BY THE DOCTOR, AND TREATMENT HAS BEEN PRESCRIBED. THERE IS NO KNOWN HISTORY OF ALLERGY; END USER IS A FIRST-TIME USER. CLINICAL EVALUATION: AS SYMPTOMS STOPPED WHEN END USER STOPPED WEARING THE HEARING AIDS, IT IS HIGHLY LIKELY THAT THE SYMPTOMS ARE RELATED TO THE HEARING AIDS. SKIN IRRITATION IS NOT UNCOMMON FOR FIRST-TIME HEARING AID USERS, AND MOST USERS BECOME ACCUSTOMED TO WEARING THE HEARING AIDS. ALLERGIC REACTION IS IDENTIFIED IN THE RISK ANALYSIS, AND MITIGATED TO AN ACCEPTABLE LEVEL THROUGH DEVICE DESIGN BY COMPLIANCE WITH STANDARDS FOR BIOCOMPATIBILITY. STILL ALLERGIC REACTIONS CAN OCCUR IN RARE CASES. THE CLINICAL EVALUATION DOES EVALUATE ALLERGIC REACTIONS, AND THE USER GUIDE INCLUDES A SAFETY NOTIFICATION INSTRUCTING THE HEARING AID WEARER TO CONTACT THE HCP IN CASE OF SKIN IRRITATION. CLINICAL CONCLUSION ON THE CASE IS THAT THE REACTION IS LIKELY RELATED TO THE HEARING AIDS, AND HAS REQUIRED MEDICAL INTERVENTION. THE ISSUE WAS CAUSED BY THE DEVICE. THIS IS A ONE OF ISSUE. WE DO NOT HAVE OTHER EVENTS RELATED TO THIS. GN RESOUND WILL TREND THE EVENT FOR 3 MONTHS.

    Description of Event or Problem · 1

    WE HEREBY FORWARD A MIR REPORT RE. AN INCIDENT IN (B)(6): ALLERGIC REACTION REPORTED BY DISPENSER. PATIENT SYMPTOM: DERMATOLOGIC IRRITATION (HEAD AND NECK) TIME OF USE BEFORE SYMPTOM APPEARED: THE REACTION APPEARED WITHIN THE FIRSTS WEEKS AND LASTED FOR THE TIME THE DEVICES WERE WORN BY THE PATIENT. THE SKIN REACTION HAS BEEN CONFIRMED BY DOCTOR (SUMMARY REPORT ATTACHED TO THE CASE). ACCORDING TO THIS REPORT, THE REACTION IS CAUSED BY THE MATERIALS USED TO PRODUCE THE DEVICE AS THE TREATMENT PRESCRIBED (NOT SPECIFIED) DID NOT PRODUCE THE EXPECTED RESULTS WHILE HE PATIENT WORE THE DEVICES, BUT THE PATIENT GOT SIGNIFICANTLY BETTER WHEN SHE STOP WEARING THE INSTRUMENTS. ALTHOUGH IT IS NOT SPECIFIED IN THE REPORT, ACCORDING TO THE CONVERSION WITH THE DISPENSER, THE DOCTOR THINKS THE REACTION WAS CAUSED BY THE NANO COATING TREATMENT (17369900 NANO COATING, ARIDION 120 C1). THE PATIENT DOES NOT HAVE A PREVIOUS HISTORY OF ALLERGIC REACTIONS, ALTHOUGH ACCORDING TO THE CONVERSATION WITH THE DISPENSER, SHE HAS A "VERY SENSITIVE" SKIN. ENVIRONMENT: ACCORDING TO THE INFORMATION PROVIDED BY THE DISPENSER, THE REACTION DOES NOT SEEM TO BE CAUSED BY WEARING THE DEVICE IN A SPECIFIC ENVIRONMENT (HOME, OUTDOOR) THE PATIENT DOES NOT USE ANY CLEANING AGENT. THE PATIENT HAS NOT WORN HEARING INSTRUMENTS BEFORE. COMPETENT AUTHORITIES: THE INCIDENT HAS NOT BEEN REPORTED TO THE ES COMPETENT AUTHORITIES. DISPENSER HAS RETURNED THE DEVICES TO GN HEARING CARE, AND THEY CAN BE SHIPPED TO DK UNDER REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922843 BELTONE BOP995-DW,BOOST PLUS 9 OSM GN HEARING A/S BOP995-DW,BOOST PLUS 9,BELTONE 05704819291462

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability