BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GN RESOUND

    MDR report key: 10539253 · Received September 16, 2020

    Report

    Report Number
    3005650109-2020-00037
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    August 18, 2020
    Report Date
    September 16, 2020
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296140275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE HAS BEEN DECIDED TO BE REPORTABLE AS THERE HAS BEEN MEDICAL INTERVENTION. THERE'S NO MALFUNCTION. THIS IS CONSIDERED A SINGLE INCIDENT AND WILL BE INCLUDED IN REGULAR TRENDING. NO CORRECTIVE ACTIONS HAS BEEN INITIATED BASED ON THIS INDIVIDUAL EVENT. THE CASE HAS BEEN REVIEWED FROM A CLINICAL PERSPECTIVE. CUSTOMER REPORTED: END USER HAS DEVELOPED A REACTION TO THE EAR MOULDS. THERE HAS BEEN NO PROBLEMS WITH FIRST SET OF EAR MOULDS, BUT REACTION STARTED AFTER RECEIVING EAR MOULDS BACK AFTER A REMAKE. REACTION STARTED 4 DAYS AFTER THE REMAKE. SYMPTOMS ARE REDNESS AND FLAKING. CURRENT STATUS IS THAT LEFT EAR HAS HEALED, BUT RIGHT EAR IS STILL RED AND A BIT FLAKY. END USER HAS CONSULTED A DERMATOLOGIST WHO PRESCRIBED MEDICATION AND ADVISED TO STOP WEARING THE EAR MOULDS. THERE IS NO KNOWN HISTORY OF ALLERGIES OR HYPERSENSITIVITY 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.

    Description of Event or Problem · 1

    AS REPORTED BY THE LOCAL SALES OFFICE: EAR MOLD REMAKE CAUSES ALLERGIC REACTION. FIRST SET OF EM'S WERE FINE - THEN THE REMAKE CAUSED ALLERGIC REACTION IN THE EARS. AFTER FITTING OF REMAKE EM'S, MEMBER COMPLAINED OF ALLERGIC REACTION CAUSING REDNESS AND FLAKING IN EAR CANAL. PICKED UP REMAKE ON (B)(6) 2020 AND WORE FOR 4 DAYS. THEN MEMBER HAD TO STOP WEARING THEM. REDNESS AND FLAKING IN THE EAR CANAL. 4 DAYS AFTER WEARING REMADE EM'S ((B)(6) 2020). LEFT EAR HAS HEALED BUT RIGHT EAR IS STILL RED AND A BIT FLAKY. MEMBER SAW DERMATOLOGIST AND MEDICATION PRESCRIBED AND MEMBER WAS TOLD TO STOP WEARING EM'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007912 GN RESOUND EM,RIE-HA-RF7-MPSF OSM GN HEARING A/S EM,RIE-HA-RF7-MPSF 05708296140275

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention