BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GN HEARING

    MDR report key: 18702524 · Received February 14, 2024

    Report

    Report Number
    3005650109-2024-00011
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 14, 2024
    Report Date
    March 15, 2024
    Manufacturer
    GN HEARING A/S
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# SF (B)(4). IT HAS BEEN CONFIRMED THAT A SERIAL NUMBER FOR THE RECEIVER IS NOT AVAILABLE. DEVICE HISTORY RECORD CANNOT BE OBTAINED. MANUFACTURER'S INVESTIGATION PENDING, TO BE SUBMITTED WHEN FINAL. THIS IS AN INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REF# SF (B)(4). IT HAS BEEN CONFIRMED THAT A SERIAL NUMBER FOR THE RECEIVER IS NOT AVAILABLE. DEVICE HISTORY RECORD CANNOT BE OBTAINED. MANUFACTURER'S INVESTIGATION PENDING, TO BE SUBMITTED WHEN FINAL. THIS IS AN INITIAL REPORT. (B)(6) 2024 MANUFACTURER'S INVESTIGATION CONLUSION: TECHNICAL INVESTIGATION CONCLUDED: DEVICE HISTORY RECORD CAN NOT BE OBTAINED, MANUFACTURER DID NOT RECEIVER SERIAL NUMBER FOR THE BROKEN RECEIVER. THE CLINICAL INVESTIGATION CONCLUDED: CLINICAL CONCLUSION IS THAT THE INCIDENT DID NOT CAUSE HARM TO THE USER. CLINICAL EVALUATION ACCORDING TO CLINICAL EVALUATION PLAN: THE CLINICAL EVALUATION FOR THE DEVICE FAMILY DOES EVALUATE RECEIVERS COMING LOOSE IN THE EAR CANAL. THIS IS IDENTIFIED IN THE RISK ANALYSIS AND MITIGATED THROUGH DEVICE DESIGN BY ENSURING A SUFFICIENT PULL FORCE (COMPLIANCE WITH IEC (B)(4)). THE USER GUIDE STATES TO CONTACT THE HCP IF A FOREIGN OBJECT OR WAX IS LOCATED IN THE EAR CANAL TO REDUCE THE POTENTIAL RISK OF HARM AS FAR AS POSSIBLE. 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. RISK REGISTER REFERENCE: THE RESIDUAL RISK AFTER THE RISK CONTROL MEASURE(S) IS ACCEPTABLE. NO NEW HAZARDOUS SITUATIONS REVEALED AND NO NEED TO UPDATE THE RISK REGISTER. ALL RESULTING ACTIONS ARE CONTAINED WITHIN THE CAPA. TRENDED CASE INVESTIGATION: FAILURE TRACED BACK TO THE MANUFACTURING PROCESS, CAPA IS INITIATED. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    DATE OF THE INCIDENT BEST ESTIMATE (B)(6) 2024. ON (B)(6) 2024 IT WAS REPORTED THAT THE RECEIVER SNAPPED OFF IN THE PATIENT'S EAR, DETACHED FROM THE DOME AND WAS STUCK IN THE PATIENT'S EAR. PATIENT WENT TO THE EMERGENCY ROOM, BUT DUE TO LONG WAIT, THE PATIENT'S WIFE USED TWEEZER TO REMOVE THE DOME FROM HIS EAR. FOLLOW UP INFORMATION REQUESTED.

    Description of Event or Problem · 0

    DATE OF THE INCIDENT BEST ESTIMATE (B)(6) 2024 ON (B)(6) 2024 IT WAS REPORTED THAT THE RECEIVER SNAPPED OFF IN THE PATIENT'S EAR, DETACHED FROM THE DOME AND WAS STUCK IN THE PATIENT'S EAR. PATIENT WENT TO THE EMERGENCY ROOM, BUT DUE TO LONG WAIT, THE PATIENT'S WIFE USED TWEEZER TO REMOVE THE DOME FROM HIS EAR. FOLLOW UP INFORMATION REQUESTED. (B)(6) 2024: IT WAS REPORTED THAT ON (B)(6) 2024 A DOME WAS STUCK IN THE EAR. THE PATIENT CAME INTO THE USER FACILITY ON (B)(6) 2024 VERY UPSET/ANGRY AS HIS RECEIVER BROKE INTO HIS EAR LEAVING THE DOME STUCK IN HIS EAR. HE DIDN'T HAVE AN OPTION TO GO TO HIS GP AND DIDN'T WANT TO SIT AND WAIT AT THE EMERGENCY DEPARTMENT. HIS WIFE ENDED UP RETRIEVING HIS DOME OUT OF HIS EAR WITH TWEEZERS. NO HARM OR INJURY CONFIRMED. HEARING CARE PROFESSIONAL (HCP) DISCUSSED OTHER OPTIONS WITH THE PATIENT, THAT WOULD MAKE HIM MORE COMFORTABLE WITH WEARING HEARING AIDS. THE PATIENT IS HAPPY WITH THE FIT OF CURRENT DEVICE AND WOULD LIKE TO CONTINUE USING IT, HOWEVER, HAS LOST CONFIDENCE REGARDING GIF A SIMILAR INCIDENT MAY HAPPEN AGAIN. HCP HAS FITTED THE PATIENT WITH A SPORTS LOCK FOR A TRIAL, SO THAT THE PATIENT CAN BE CONFIDENT THAT HE NOW HAS A SAFE WAY TO REMOVE RECEIVER/DOME FROM EARS. IF THE PATIENT DOES NOT LIKE THE SOLUTION NEXT STEP WILL BE TO TRY CANAL LOCK MOULD. NO FURTHER INFORMATION EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82026 GN HEARING HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY OSM GN HEARING A/S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male