BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GN RESOUND

    MDR report key: 15461173 · Received September 21, 2022

    Report

    Report Number
    3005650109-2022-00037
    Event Type
    Injury
    Date Received
    September 21, 2022
    Report Date
    September 21, 2022
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296207428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL INVESTIGATION: A DEVICE HISTORY REGISTER REVIEW HAVE BEEN COMPLETED. NO DEVIATION OR CHANGES WERE FOUND DURING MANUFACTURING OF THE DEVICE. CLINICAL EVALUATION OF THE EVENT: AS HEARING AIDS ARE DESIGNED TO HAVE SKIN CONTACT WITH THE END USER, THE MATERIALS USED IN THE HEARING AIDS ARE BIOCOMPATIBLE AND A BIOLOGICAL EVALUATED ACCORDING TO PROCEDURE #00066720 CORP PROC,BIOL EVALUATION. A GENERIC MATERIAL LIST IS PROVIDED IN #0332250 MATERIALS USED IN GN HEARING PRODUCTS. CASE INFORMATION STATES THAT END USER IS EXPERIENCING AN ALLERGIC REACTION IN THE EAR CANALS WHERE THE HEARING INSTRUMENTS MAKE CONTACT WITH THE SKIN. CLINICAL CONCLUSION ON THE CASE IS THAT THE REACTION WAS CAUSED BY USE OF THE HEARING AIDS AND THAT CHANGING DEVICES OR DEVICE MATERIAL IS APPROPRIATE. CLINICAL EVALUATION ACCORDING TO CORP PROC GEN EVALUATION 0185290: 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. THERE ARE NO NEW CLINICAL ASPECTS (E.G. UNFORESEEN USE OR CLINICAL CONDITIONS) DISCOVERED FROM THIS EVENT. THEREFORE, IT IS CONCLUDED THAT THE CURRENT CLINICAL EVALUATION AND RISK/BENEFIT CONCLUSIONS HEREIN ARE SUFFICIENT. RISK REGISTER REFERENCE: THE RESIDUAL RISK AFTER THE RISK CONTROL MEASURE(S) IS ACCEPTABLE. NO NEW HAZARDOUS SITUATIONS REVEALED AND NO NEED TO UPDATE THE RISK REGISTER BASED ON THE ABOVE INFORMATION THE CASE IS CONSIDERED REPORTABLE AS THE INCIDENT DID LEAD TO, OR MIGHT HAVE LED TO A SERIOUS INJURY IF IT RECURRED. THIS IS A FINAL REPORT. THIS CASE IS CONSIDERED AS A SINGLE INCIDENT AND WILL BE INCLUDED IN REGULAR TRENDING. NO ACTIONS HAVE BEEN INITIATED BASED ON THIS INDIVIDUAL EVENT.

    Description of Event or Problem · 0

    ON 25-AUG-2022 IT WAS REPORTED THAT THE PATIENT ON UNKNOWN DATE CHANGED FROM CUSTOM HEARING AID TO RECEIVER-IN-CANAL HEARING AID, BECAUSE OF INFECTION IN BOTH EAR CANALS. THE PATIENT EXPERIENCED PAIN IN THE EAR CANAL, WHEN THE HEARING AIDS WERE IN DURING THE DAY, AND BECAUSE OF THE PAIN THEY WERE REMOVED. AT NIGHT THE PATIENT EXPERIENCED DRAINAGE. SYMPTOMS REPORTED: REDNESS, PAIN, INFLAMMATION AND EAR DISCHARGE/FLUID. THE PATIENT HAS NEVER EXPERIENCED THIS BEFORE. HEARING AID ARE A YEAR OLD AND THE PAIN WAS RECENT. NO KNOWN HISTORY OF ALLERGIES OR HYPERSENSITIVITY. ON UNKNOWN DATE, THE PATIENT WAS IN CONTACT WITH A MEDICAL PRACTIONER, WHO CONCLUDED THAT THE DRAINAGE WAS NON-INFECTIOUS, NO WOUNDS IN THE EAR CANAL OR CONCHA BOWL AND NO EFFUSION, AND RECOMMENDED THAT THE PATIENT SWITCHED TO A BEHIND-THE-EAR HEARING AID STYLE OR REFIT THE CUSTOM DEVICES AND FOLLOW-UP IN 3 MONTHS. PAIN IS SUSPECTED TO BE RELATED TO THE PHYSICAL FIT OF THE HEARING AIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791949 GN RESOUND HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S KE2ITC-DW-MP 05708296207428

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other