BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOUND

    MDR report key: 10337485 · Received July 29, 2020

    Report

    Report Number
    3005650109-2020-00023
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 30, 2020
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION: 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 REQUIRED MEDICAL INTERVENTION. FINAL CONCLUSION: THIS CASE IS EVALUATED AS REPORTABLE AND THIS FINAL MDR REPORT FILED TO THE FDA. THE REASON IS THAT THERE HAS BEEN MEDICAL INTERVENTION IN THE FORM OF PRESCRIPTION OF TRIAMCINOLONE CREAM. IN GENERAL END USER IS SENSITIVE TO TRADITIONAL CUSTOM EAR MOULDS, BUT HAS NOT PREVIOUSLY HAD ANY REACTION TO THE BTE STYLE. NO PERMANENT HARM IS REPORTED.

    Description of Event or Problem · 1

    AS REPORTED: ALLERGIC REACTION ON TOP OF EARS. REPORTED ALLERGIC REACTION ON BOTH SIDES ON TOP OF EARS. BOTH HEARING AIDS (SNS INCLUDED IN CASE) CAUSED TOPS OF EARS TO BE IRRITATED. THIS OCCURRED AT PATIENT HOUSE. END USER WENT TO MEDICAL DOCTOR ON MONDAY, JUNE 29TH. WAS PRESENT BEFORE, BUT HCP NOT SURE WHEN IT STARTED. HCP SAW PATIENT ON JUNE 25TH AND NOTHING MENTIONED ABOUT THE IRRITATION. HCP DID NOT LOOK IN HER EARS AT THAT TIME, BUT END USER DID NOT REPORT. END USER WAS PRESCRIBED A CREAM TO HELP WITH THE IRRITATION. THEY ARE CURRENTLY USING CREAM. END USER WAS PRESCRIBED TRIAMCINOLONE CREAM. INTERPRETATION: END USER EXPERIENCED IRRITATION ON TOP OF BOTH EARS. END USER WAS PRESCRIBED TRIAMCINOLONE CREAM. IN GENERAL END USER IS SENSITIVE TO TRADITIONAL CUSTOM EAR MOULDS, BUT HAS NOT PREVIOUSLY HAD ANY REACTION TO THE BTE STYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801266 RESOUND LINX QUATTRO 9 OSM GN HEARING A/S RE961-DRWC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention