BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOUND

    MDR report key: 10206132 · Received June 29, 2020

    Report

    Report Number
    3005650109-2020-00022
    Event Type
    Injury
    Date Received
    June 29, 2020
    Date of Event
    March 14, 2020
    Report Date
    June 29, 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

    AS REPORTED PATIENT HAS REDNESS AND SWELLING IN BOTH EARS WHILE WEARING HEARING AIDS AND AFTER HAVING TAKEN THEM OUT. PT HAS BEEN WEARING HA'S FOR TWO YEARS WITH NO ISSUES BUT 2-3 WKS AGO SWELLING NOTED IN BOTH EAR CANALS AND LOBES BY NURSING HOME MD, CONCERNS ABOUT INFECTION. REPORTEDLY CHECKED AGAIN BY MD = NO CONCERNS OF INFECTION A WK AGO. PT IN THE OFFICE TODAY, KEN REPORTS THAT PATIENT HAS RED AND SWOLLEN EAR CANALS AND LOBES. PT. HASN'T BEEN WEARING HA'S FOR A COUPLE WEEKS, STILL HAS SWELLING/REDNESS. HE TRIED TO PUT A HA IN EAR LAST WK BUT IT HURT AND FELL OUT, ISN'T FITTING. NO PAIN/BURNING/ITCHING. PAIN IF HA IS ATTEMPTED TO PUT INTO EAR. PT. STAYS @ NURSING HOME WHERE HA'S ARE KEPT IN CABINET. WHEN SYMPTOMS STARTED THEY TOOK HIM TO HAVE WAX CLEANED OUT, GIVEN "SOME DROPS" (UNKNOWN AS TO WHAT THEY WERE FOR). NOT USING CLEANING AGENT WITH HEARING AIDS. CUSTOMER IS GOING TO REFER PATIENT TO ENT BASED UPON HIS CONCERNS, AND HAS TOLD PATIENT TO NOT WEAR HEARING AIDS FOR NOW. I FLAGGED HA'S IN NAVISION, CUSTOMER WILL SEND INTO US WITH PRODUCT AUTH FORM. COMPLAINT CREATED. NEW CASE UPDATE PER (B)(4); CUSTOMER SAID THAT THE NURSING HOME ACCIDENTALLY SWITCHED HEARING AIDS, MIXED THEM UP WITH SOMEONE ELSE'S HEARING AIDS AT THE NURSING HOME. THE S/N'S THAT THE CUSTOMER PROVIDED ME WITH WERE THE S/N'S IN PATIENTS NOAH FILE, BUT HE DIDN'T LOOK ON THE HA'S THEMSELVES WHEN THE PATIENT HAD COME INTO THE OFFICE. OTHER NURSING HOME RESIDENT ALSO WEARS HA'S AND IS ALSO FIT BY THIS PROVIDER. HE IS GOING TO SEND THESE HA'S BACK TO THE NURSING HOME SO OTHER PATIENT CAN START WEARING THEM AGAIN, AND HE THINKS THAT THE NURSING HOME FOUND THIS PATIENT'S OWN HEARING AIDS. NO WORD ON HOW PATIENT IS DOING EXCEPT FOR THAT THE NURSING HOME WAS TRYING TO PUT SOMEONE ELSE'S HEARING AIDS INTO THIS PATIENT'S EARS WHICH IS WHAT THEY SUSPECT THE ISSUE WAS. S/N (B)(4) (LEFT). MANUFACTURING DATE 06/02/2018 - LEFT. INFORMATION AFTER INITIAL CONCLUSION NOT TO REPORT NEW INFORMATION EMERGED END OF MAY 2020 AND A NEW CLINICAL EVALUATION WAS PERFORMED JUNE 19, 2020 WHICH INDICATED THAT THERE MIGHT HAVE BEEN A MEDICAL INTERVENTION (EAR DROPS PRESCRIBED) TO PRECLUDE SERIOUS INJURY (POTENTIAL INFECTION) EVEN THOUGH PREVIOUS DIAGNOSIS SAW NO SIGNS OF AN INFECTION. (B)(6), CLINICAL EVALUATION: (B)(6) 2020 11:53:26 AM CBENTZON. THE CASE HAS BEEN REVIEWED FROM A CLINICAL PERSPECTIVE. CUSTOMER REPORTED: END USER SUDDENLY EXPERIENCES REDNESS AND SWELLING IN BOTH EARS WHILE WEARING HEARING AIDS AND AFTER HAVING TAKEN HEARING AIDS OUT OF EAR. SYMPTOMS ARE PAIN, BURNING, REDNESS AND INFLAMMATION. END USER HAS CONSULTED AN DOCTOR AND HAD EARWAX REMOVED AND DROPS WERE PRESCRIBED. FOLLOW-UP STATES THAT NURSING HOME ACCIDENTALLY SWITCHED HEARING AIDS AND MIXED THEM UP WITH SOMEONE ELSE'S HEARING AIDS. SYMPTOMS ARE REDNESS AND INFLAMMATION. WHEN HEARING AIDS ARE INSERTED, HE FEELS PAIN AND BURNING IN EAR. 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. UPDATED CASE DESCRIPTION STATES THAT THE HEARING AIDS HAVE BEEN SWAPPED WITH ANOTHER USER'S HEARING AIDS. THIS MEANS THAT THE EAR MOULDS, THAT ARE CUSTOMIZED BY EAR IMPRESSION TO THE EAR, WILL NOT FIT AND WILL MOST LIKELY CAUSE PRESSURE PAIN AND SKIN REACTION IN THE EAR. FURTHER, THE SURFACE ON HEARING AIDS WILL CONTAIN FOREIGN BACTERIA. LISTED CASE SYMPTOMS ARE REDNESS, INFLAMMATION, SWELLING, PAIN AND BURN IN EAR. FURTHER, DROPS HAVE BEEN PRESCRIBED BY A DOCTOR. CLINICAL CONCLUSION IS THAT IT IS HIGHLY LIKELY THAT THE SWAP OF HEARING AIDS HAS CAUSED THE LISTED SYMPTOMS AND THAT THIS HAS REQUIRED MEDICAL INTERVENTION (DROPS PRESCRIBED BY DOCTOR). FINAL CONCLUSION INFORMATION AVAILABLE AT THE TIME OF THE INITIAL 30-DAY LIMIT SUPPORTS THE PREVIOUS DECISION NOT TO REPORT. HOWEVER NEW ADDITIONAL INFORMATION (EMERGING ONE MONTH AFTER THE INITIAL 30 DAY-DECISION, DESPITE THE FACT THAT PREVIOUS ATTEMPTS TO RETRIEVE THE SAME INFORMATION WERE UNSUCCESSFUL) SUGGESTS THAT THE DROPS "GIVEN" WERE INDEED PRESCRIBED BY A MD AT THE NURSING HOME AND NOT JUST "GIVEN" (AND WHERE THERE PREVIOUSLY WERE UNCERTAINTY FOR WHAT AND BY WHOM). IT IS STILL BELIEVED THAT THE SWELLING IS CAUSED BY THE MIX UP OF THE DEVICE BETWEEN TWO PATIENTS AT THE NURSING HOME (AND MOST LIKELY A TOO BIG HEARING AID HAS BEEN FORCED INTO THE EAR OF "OUR" PATIENT). THIS IS ALSO SUPPORTED BY PREVIOUS EMAIL CONVERSATION WITH THE CASE OWNER. HOWEVER, THE NEW INFORMATION INDICATE THAT THE DROPS COULD HAVE BEEN PRESCRIBED TO TREAT OR CURE THE SWELLING WHICH MAKES IT A MEDICAL INTERVENTION IN ORDER TO PRECLUDE A SERIOUS INJURY AND IS THUS DEEMED TO BE REPORTABLE. THEREFORE THIS CASE IS REPORTED AS A MEDICAL INTERVENTION, NEEDED TO PRECLUDE A SERIOUS INJURY. THE DEVICE HAS NOT MALFUNCTIONED, BUT THE WRONG DEVICE WAS INSERTED INTO THE EAR OF THE PATIENT WHICH CAUSED BAD PHYSICAL FIT AND SWELLING AND REDNESS AND A POTENTIAL INFECTION. THE EVENT IS USER ERROR RELATED AS THE EVENT WOULD MOST LIKELY NOT OCCUR IF THE MIX-UP OF DEVICE HAD NOT HAPPENED.

    Description of Event or Problem · 1

    AS REPORTED PATIENT HAS REDNESS AND SWELLING IN BOTH EARS WHILE WEARING HEARING AIDS AND AFTER HAVING TAKEN THEM OUT. PT HAS BEEN WEARING HA'S FOR TWO YEARS WITH NO ISSUES BUT 2-3 WKS AGO SWELLING NOTED IN BOTH EAR CANALS AND LOBES BY NURSING HOME MD, CONCERNS ABOUT INFECTION. REPORTEDLY CHECKED AGAIN BY MD = NO CONCERNS OF INFECTION A WK AGO. PT IN THE OFFICE TODAY, KEN REPORTS THAT PATIENT HAS RED AND SWOLLEN EAR CANALS AND LOBES. PT. HASN'T BEEN WEARING HA'S FOR A COUPLE WEEKS, STILL HAS SWELLING/REDNESS. HE TRIED TO PUT A HA IN EAR LAST WK BUT IT HURT AND FELL OUT, ISN'T FITTING. NO PAIN/BURNING/ITCHING. PAIN IF HA IS ATTEMPTED TO PUT INTO EAR. PT. STAYS @ NURSING HOME WHERE HA'S ARE KEPT IN CABINET. WHEN SYMPTOMS STARTED THEY TOOK HIM TO HAVE WAX CLEANED OUT, GIVEN "SOME DROPS" (UNKNOWN AS TO WHAT THEY WERE FOR). NOT USING CLEANING AGENT WITH HEARING AIDS. CUSTOMER IS GOING TO REFER PATIENT TO ENT BASED UPON HIS CONCERNS, AND HAS TOLD PATIENT TO NOT WEAR HEARING AIDS FOR NOW. I FLAGGED HA'S IN NAVISION, CUSTOMER WILL SEND INTO US WITH PRODUCT AUTH FORM. COMPLAINT CREATED. NEW CASE UPDATE PER (B)(4); CUSTOMER SAID THAT THE NURSING HOME ACCIDENTALLY SWITCHED HEARING AIDS, MIXED THEM UP WITH SOMEONE ELSE'S HEARING AIDS AT THE NURSING HOME. THE S/N'S THAT THE CUSTOMER PROVIDED ME WITH WERE THE S/N'S IN PATIENTS NOAH FILE, BUT HE DIDN'T LOOK ON THE HA'S THEMSELVES WHEN THE PATIENT HAD COME INTO THE OFFICE. OTHER NURSING HOME RESIDENT ALSO WEARS HA'S AND IS ALSO FIT BY THIS PROVIDER. HE IS GOING TO SEND THESE HA'S BACK TO THE NURSING HOME SO OTHER PATIENT CAN START WEARING THEM AGAIN, AND HE THINKS THAT THE NURSING HOME FOUND THIS PATIENT'S OWN HEARING AIDS. NO WORD ON HOW PATIENT IS DOING EXCEPT FOR THAT THE NURSING HOME WAS TRYING TO PUT SOMEONE ELSE'S HEARING AIDS INTO THIS PATIENT'S EARS WHICH IS WHAT THEY SUSPECT THE ISSUE WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670093 RESOUND LINX2 OSM GN HEARING A/S LS5 ITE-DW UP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention