GN HEARING A/S
Report
- Report Number
- 3005650109-2023-00144
- Event Type
- Injury
- Date Received
- November 16, 2023
- Date of Event
- October 1, 2023
- Report Date
- December 14, 2023
- Manufacturer
- GN HEARING A/S
- Product Code
- OSM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MANUFACTURER'S REF#: (B)(4). INVESTIGATION IS ONGOING, A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.
MANUFACTURER'S REF# (B)(4). INVESTIGATION IS ONGOING, A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION. 14DEC2023. CLINICAL EVALUATION: IT WAS REPORTED THAT THE PATIENT'S EAR HAS BEEN IRRITATED TO THE POINT OF BLEEDING DUE TO HEARING AID. REPORTED SYMPTOMS ARE REDNESS, PAIN, SORES AND INFLAMMATION. THE SYMPTOMS ARE PRESENT ON BOTH EARS. PATIENT IS ALLERGIC TO NICKEL BUT UNSURE IF THIS IS THE PROBLEM OR IF IT A PHYSICAL FIT ISSUE OR SOMETHING ELSE. HEARING CARE PROFESSIONAL (HCP) 'INHERITED' THIS PATIENT THEREFORE HAS LIMITED INFORMATION ON PATIENT'S HISTORY. HCP REPORTS THAT THE PATIENT TOLD HER THAT SEVERAL TYPES/SIZES OF DOMES HAVE BEEN TRIED BUT THE IRRITATION KEEPS COMING BACK. PATIENT REPORTS GOING TO SEE A PHYSICIAN AND HE WAS PRESCRIBED 2 TYPES OF CREAM, HE REPORTS ONE WAS A STEROID AND THE OTHER ONE HE COULD NOT REMEMBER WHAT IT WAS. FOLLOW UP INFORMATION IS NOT AVAILABLE. IT CANNOT BE DISMISSED THAT THE SKIN REACTION HAS BEEN CAUSED BY HEARING AID OR ITS PARTS. IT IS ADVISED FOR HCP TO TRY OUT DIFFERENT FITTING SOLUTIONS TO HELP THE SYMPTOMS, INCLUDING CUSTOM MADE EARMOLDS TO SEE IF THE SYMPTOMS ARE DUE TO POOR PHYSICAL IT. CLINICAL ASSESSMENT IS THAT IT IS UNLIKELY THAT THE INCIDENT CAN CAUSE SERIOUS HARM TO THE PATIENT, HOWEVER, IF THE SYMPTOMS PERSIST AND OTHER FITTING SOLUTION DO NOT HELP, IT IS ADVISED TO CONSIDER DISCONTINUING USE OF HEARING AIDS AND SEE IF THAT HELPS THE CONDITION. 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. THE USER GUIDE INCLUDES A CAUTION TO CONSULT THE HEARING CARE PROFESSIONAL IF IRRITATION SHOULD OCCUR. 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. POOR PHYSICAL FIT OF HEARING AIDS IS IDENTIFIED IN THE RISK ANALYSIS AND MITIGATED TO AN ACCEPTABLE LEVEL THROUGH MODIFICATION OF THE HEARING AID CASING OR A REMAKE OF THE HEARING AID. THE USER GUIDE INSTRUCTS THE HEARING AID TO CONTACT THE HEARING CARE PROFESSIONAL IF SKIN IRRITATION OCCURS. 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. MANUFACTURER'S INVESTIGATION IS FINAL. THIS IS A FINAL REPORT.
DATE OF INCIDENT ON (B)(6) 2023, BEST ESTIMATE ON (B)(6) 2023 IT WAS REPORTED: USER'S EAR HAS BEEN IRRITATED TO THE POINT OF BLEEDING DUE TO HEARING AID. USER IS ALLERGIC TO NICKEL BUT UNSURE IF THIS IS THE PROBLEM OR IF IT A PHYSICAL FIT ISSUE OR SOMETHING ELSE. HEALTH CARE PROVIDER (HCP) REPORTS THAT USER REPORTS HAVING IRRITATION IN HIS EAR CANAL ON AND OFF SINCE HE HAS HAD THEM AND HAS ALSO BLED FROM THE IRRITATION AT SOME POINT. REACTION IS PRESENT ON BOTH EARS. THIS HCP INHERITED THIS PATIENT SO SHE HAS LIMITED INFORMATION ON HIS FULL HISTORY. USER HAS HAD THE HEARING AIDS SINCE ON (B)(6) 2022 AND HEALTH CARE PROVIDER REPORTS THAT SHE BELIEVES USER HAS HAD TROUBLE SINCE HE FIRST GOT THE AIDS. HCP REPORTS THAT THE PATIENT TOLD HER THAT SEVERAL TYPES/SIZES OF DOMES HAVE BEEN TRIED BUT THE IRRITATION KEEPS COMING BACK. USER REPORTS GOING TO SEE A PHYSICIAN AND HE WAS PRESCRIBED 2 TYPES OF CREAM, HE REPORTS ONE WAS A STEROID AND THE OTHER ONE HE COULD NOT REMEMBER WHAT IT WAS. HCP DIDN'T PROVIDE ITEM NUMBER OR SERIAL NUMBER. NO FURTHER INFORMATION IS EXPECTED.
DATE OF INCIDENT (B)(6) 2023 - BEST ESTIMATE. ON 17OCT2023 IT WAS REPORTED: USER'S EAR HAS BEEN IRRITATED TO THE POINT OF BLEEDING DUE TO HEARING AID. USER IS ALLERGIC TO NICKEL BUT UNSURE IF THIS IS THE PROBLEM OR IF IT A PHYSICAL FIT ISSUE OR SOMETHING ELSE. HEALTH CARE PROVIDER (HCP) REPORTS THAT USER REPORTS HAVING IRRITATION IN HIS EAR CANAL ON AND OFF SINCE HE HAS HAD THEM AND HAS ALSO BLED FROM THE IRRITATION AT SOME POINT. REACTION IS PRESENT ON BOTH EARS. THIS HCP INHERITED THIS PATIENT SO SHE HAS LIMITED INFORMATION ON HIS FULL HISTORY. USER HAS HAD THE HEARING AIDS SINCE MARCH 2022 AND HEALTH CARE PROVIDER REPORTS THAT SHE BELIEVES USER HAS HAD TROUBLE SINCE HE FIRST GOT THE AIDS. HCP REPORTS THAT THE PATIENT TOLD HER THAT SEVERAL TYPES/SIZES OF DOMES HAVE BEEN TRIED BUT THE IRRITATION KEEPS COMING BACK. USER REPORTS GOING TO SEE A PHYSICIAN AND HE WAS PRESCRIBED 2 TYPES OF CREAM, HE REPORTS ONE WAS A STEROID AND THE OTHER ONE HE COULD NOT REMEMBER WHAT IT WAS. HCP DIDN'T PROVIDE ITEM NUMBER OR SERIAL NUMBER. NO FURTHER INFORMATION IS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 229065 | GN HEARING A/S | HEARING AID, , AIR CONDUCTION WITH WIRELESS TECHNOLOGY | OSM | GN HEARING A/S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |