BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOUND

    MDR report key: 10424253 · Received August 19, 2020

    Report

    Report Number
    3005650109-2020-00026
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 9, 2020
    Report Date
    August 19, 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

    THE EM WAS BUILT ACCORDING TO SPECIFICATION. THERE WAS NO PRESSURE SPOT OBSERVED FROM E-SCULPTING FILE. THE CASE HAS BEEN REVIEWED FROM A CLINICAL PERSPECTIVE. CUSTOMER REPORTED: END USER IS EXPERIENCING IRRITATION IN THE EAR BECAUSE THE EAR MOULD IS RUBBING EAR, CONCHA PART. SYMPTOMS ARE REDNESS AND SORENESS END USER HAS CONSULTED A DOCTOR AND MEDICATION HAS BEEN PRESCRIBED. DOCTOR ADVISED TO TRIM THE EAR MOULD. THE EAR MOULD HAS BEEN RETURNED FOR REMAKE. THE CLINICAL EVALUATION FOR THE DEVICE FAMILY DOES EVALUATE SORENESS FROM PHYSICAL FIT AND AS A RESULT OF THIS, THE NECESSITY OF MAKING ADJUSTMENTS TO THE FIT OR CONSIDERING A DIFFERENT STYLE IF WEARING COMFORT CANNOT BE OBTAINED. THE USER GUIDE CONTAINS A WARNING, INSTRUCTING THE HEARING AID USER TO CONTACT THE HEARING CARE PROFESSIONAL IF SKIN IRRITATION OCCURS. CLINICAL CONCLUSION ON THE CASE IS THAT BASED ON THE CASE DESCRIPTION IT IS EVALUATED LIKELY THAT THE SORENESS IS A RESULT OF A POOR PHYSICAL FIT AND THAT THE SORENESS HAS REQUIRED MEDICAL INTERVENTION. GP CERTIFICATE STATES SYMPTOMS IMPROVED FOR END USER WITH TOPICAL APPLICATION OF OINTMENT AND HAF A QUICK RECOVERY. NEW EM MADE AND PROVIDED TO THE END USER.

    Description of Event or Problem · 1

    WE HEREBY FORWARD A MIR REPORT RE. AN INCIDENT IN (B)(6) FOR YOUR INFORMATION. PATIENT DEVELOPED REDNESS AND SORENESS IN THE RIGHT EAR DUE TO EARMOULD. PATIENT VISITED GP WHO PROVIDED MEDICATION AND RECOMMENDED AUDIOLOGIST REQUESTED A TRIM TO THE EARMOULD IN THE AREA. THAT WAS CAUSING THE PRESSURE SORE. MEDICAL CERTIFICATE PROVIDED BY PATIENT. PATIENT IS EXPERIENCED. WITH USING EARMOULDS AND IS AWARE OF CLEANING REQUIREMENTS. EM WAS ORIGINALLY MANUFACTURED IN NOVEMBER 2019. INFORMATION FROM CLINICIAN INDICATES THE END USER VISITED THE GP IN (B)(6) 2020. ADVERSE EVENT REPORTED TO GN HEARING (B)(4) PTY LTD IN MAY 2020 THROUGH CLINICIAN. DELAY BETWEEN GP VISIT AND END USER VISIT TO CLINICIAN LIKELY TO BE DUE TO COVID19 IMPACTS IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893132 RESOUND EARMOULDS, SOFT, SILICON, S25 OSM GN HEARING A/S EM, SOFT, SILICON, S25

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability