BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOUND LINX QUATTRO

    MDR report key: 12777079 · Received November 9, 2021

    Report

    Report Number
    3005650109-2021-00016
    Event Type
    Injury
    Date Received
    November 9, 2021
    Date of Event
    August 5, 2021
    Report Date
    November 9, 2021
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296145485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATION FINDINGS: THE CASE HAS BEEN REVIEWED FROM A CLINICAL PERSPECTIVE. CUSTOMER REPORTED: END USER REPORTS INFECTION AND OOZING IN EAR CANAL. SYMPTOMS ARE EAR DISCHARGE/FLUID AND INFECTION. THE SYMPTOMS ARE LOCATED IN THE EAR CANAL (AREA IN CONTACT WITH THE DOME). ANTIBIOTICS HAS BEEN PRESCRIBED AND THE END USER HAD A PAUSE IN WEARING THE HEARING AID UNTIL SYMPTOMS DISAPPEARED. WHEN BEGINNING WEARING THE HEARING AID AGAIN. THE END USER HAS NOT WORN HEARING AIDS BEFORE AND DOES NOT HAVE A PREVIOUS HISTORY OF ALLERGIC REACTIONS. CLINICAL EVALUATION OF THE EVENT: THE INFORMATION THAT THE SYMPTOMS STARTS AGAIN, WHEN THE END USER STARTS WEARING THE HEARING AID AGAIN INDICATES THAT THE REACTION IS RELATED TO THE HEARING AID. A SOLUTION FOR ALLERGIC REACTIONS CAN BE HYPOALLERGENIC MOULDS AS AN ALTERNATIVE TO THE DOME. CLINICAL CONCLUSION ON THE CASE IS THAT THE REACTION THAT HAS REQUIRED MEDICAL INTERVENTION IS LIKELY RELATED TO THE HEARING AID. 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. DEVICE MANUFACTURED ACCEPTED TO SPECIFICATIONS, ALL INSPECTIONS PASSED AND NO DEVIATIONS/CHANGES IMPLEMENTED DURING THE PRODUCTION. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT SYMPTOMS: EAR DISCHARGE/FLUID, INFECTION. THE SYMPTOMS ARE LOCATED IN THE EAR CANAL (AREA IN CONTACT WITH THE DOME) AND DO NOT SEEM TO BE RELATED TO THE REPAIR PERFORMED ON (B)(6) 2021. THE SYMPTOMS APPEARED FOR THE FIRST-TIME BEGINNING (B)(6) 2021, BUT THE CASE WAS NOT NOTIFIED TO (B)(6). THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND DID NOT WEAR THE DEVICE AGAIN UNTIL THE EAR CANAL HEALED COMPLETELY ((B)(6)). ON (B)(6), AFTER 12 DAYS OF USE, THE SYMPTOMS APPEARED AGAIN. TIME OF USE BEFORE SYMPTOM APPEARED: 18 DAYS (FIRST TIME), 12 DAYS (SECOND TIME). THE CASE HAS BEEN CONFIRMED BY A DOCTOR. THE PATIENT HAS NOT WORN HEARING INSTRUMENTS BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677982 RESOUND LINX QUATTRO HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S RE561-DRWC,LINX QUATTRO 5,GN RESOUND 05708296145485

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention