BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GN RESOUND

    MDR report key: 10835001 · Received November 13, 2020

    Report

    Report Number
    3005650109-2020-00044
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    October 14, 2020
    Report Date
    November 13, 2020
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    UDI-DI
    05708296171019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 NO MALFUNCTION. THIS IS CONSIDERED A SINGLE INCIDENT AND WILL BE INCLUDED IN REGULAR TRENDING. NO ACTIONS HAS BEEN INITIATED BASED ON THIS INDIVIDUAL EVENT. THE CASE HAS BEEN REVIEWED FROM A CLINICAL PERSPECTIVE. CUSTOMER REPORTED: THE END USER HAS CONTACTED THE HCP TO FIND OUT WHETHER THERE IS NICKEL IN THE RECEIVERS, AS SHE IS EXPERIENCING SKIN IRRITATION IN BOTH EARS WHEN WEARING THE HEARING AIDS. END USER IS VERY SENSITIVE TO METALS LIKE NICKEL IN JEWELRY AND TYPICAL GETS RASH WHEN WEARING JEWELRY. END USER'S PREVIOUS HEARING AIDS WAS ALSO RESOUND AND SHE DID NOT EXPERIENCE ANY PROBLEMS WITH THEM. THE END USER HAS CONSULTED A DOCTOR WHO PRESCRIBED CORTISONE. SHE IS CURRENTLY NOT WEARING THE HEARING AIDS. CLINICAL EVALUATION OF THE EVENT: NICKEL IS ONLY USED INTERNALLY IN GN HEARING PRODUCTS (E.G. RECEIVERS), BUT A PERSON HIGHLY SENSITIVE TO NICKEL CAN REACT TO THIS. BASED ON CASE INFORMATION IT IS EVALUATED LIKELY THAT THE END USER IS EXPERIENCING A REACTION TO THE RECEIVERS. THEREFORE, HYPOALLERGENIC EARMOULDS IS A POTENTIAL ALTERNATIVE SOLUTION. AS THE ALLERGY TO METAL, E.G. NICKEL, IS AN ALREADY PRESENT CONDITION, IT IS EVALUATED UNLIKELY THAT THE HEARING AIDS HAVE CAUSED A NEW ALLERGY. HOWEVER, IT IS HIGHLY LIKELY THAT THEY HAVE CONTRIBUTED TO THE REACTION. CLINICAL CONCLUSION ON THE CASE IS THAT IT IS HIGHLY LIKELY THAT THE HEARING AIDS HAVE CONTRIBUTED TO THIS REACTION, REQUIRING MEDICAL INTERVENTION (CORTISONE). 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.

    Description of Event or Problem · 1

    AS REPORTED BY LOCAL CUSTOMER SERVICE: HCP CALLING TO GET INFORMATION ABOUT METALS IN RECEIVER AS PATIENT REPORTING ITCHINESS. PATIENT CALLED HCP TO FIND OUT WHETHER THERE IS NICKEL IN OUR RECEIVERS. PATIENT IS REPORTING ITCHINESS IN BOTH EARS. THE PATIENT SAID SHE WENT TO THE DOCTOR AND THEY GAVE HER CORTISONE FOR HER EARS. THE HCP SAID THAT THE PATIENT HAS STOPPED WEARING THE INSTRUMENTS. SHE USES TULIP DOMES. THE HCP SAID THAT THE PATIENT DOES NOT HAVE A SIMILAR REACTION WHEN SHE USES HER OLD INSTRUMENTS WHICH ARE FORZAS. SHE WAS FIT IN JULY, AND WHEN SHE WAS FIT INITIALLY, SHE INITIALLY COMPLAINED OF MILD ITCHINESS. HOWEVER, SHE HAS NOT COME IN WITH THAT COMPLAINT SINCE HER INITIAL FITTING. THEY SET AN APPOINTMENT FOR THE PATIENT TO COME INTO THE OFFICE ON OCTOBER 22ND. THE HCP SAID THAT THE PATIENT IS VERY SENSITIVE TO METALS IN JEWELRY, AND TYPICALLY GETS A RASH WITH METAL JEWELRY. THE HCP WAS UNABLE TO ANSWER ANY SPECIFIC QUESTIONS AS THE PATIENT WAS NOT THERE AND SHE HAS NOT BEEN ABLE TO EXAMINE HER EARS. I WILL BE EMAILING HER FOLLOW-UP QUESTIONS. COMPLAINT CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299814 GN RESOUND PZ861-DRWC,PREZA 8 OSM GN HEARING A/S PZ861-DRWC,PREZA 8,GN RESOUND 05708296171019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention