GN RESOUND
Report
- Report Number
- 3005650109-2022-00005
- Event Type
- Injury
- Date Received
- May 31, 2022
- Report Date
- June 27, 2022
- Manufacturer
- GN HEARING A/S
- Product Code
- OSM
- UDI-DI
- 05708296140275
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
CLINICAL ASSESSMENT CONCLUSION THE CASE HAS BEEN REVIEWED FROM A CLINICAL PERSPECTIVE. CUSTOMER REPORTED: THEN END USER USED TO WEAR ACRYLIC EARMOLDS WHICH CAUSED PAIN AND BURNING IN RIGHT EAR. THE HCP SWITCHED TO SILICONE DOMES (TULIP) EM,RIE-HA-RF7-MPSF END USER REPORTED EXPERIENCING IRRITATION, ITCHING, INFLAMMATION IN RIGHT EAR. THE ISSUE HAS NOT OCCURRED BEFORE. THE END USER REPORTED HAVING NO KNOWN ALLERGIES. THE END USERS WAS REFERRED TO ENT WHO FOUND THE REACTION TO BE A FUNGAL INFECTION 'CANDIDA PARATSILOSIS' - THE SAME RESULTS "AS SOMEONE WHO WEARS PROSTHETICS". END USER WAS TREATED WITH AN ANTI FUNGAL (TOPICAL AND ORAL). HCP REPORTED THAT PATIENT WEARS CPAP MACHINE AND HAS THE SAME IRRITATION UNDER HIS NOSE WHERE A SILICONE PORTION RUBS ON HIS SKIN. THE END USER WAS RECOMMENDED TO STOP WEARING THE HEARING AIDS UNTIL A SOLUTION COULD E FOUND. THE HCP WILL INVESTIGATE ALTERNATIVE DOMES FROM OTHER MANUFACTURERS' (MATERIAL LISTS REQUESTED) TO TRY THEM OUT. CLINICAL EVALUATION OF THE EVENT: AS HEARING AIDS ARE DESIGNED TO HAVE SKIN CONTACT WITH THE END USER, THE MATERIALS USED IN THE HEARING AIDS ARE BIOCOMPATIBLE AND A BIOLOGICAL EVALUATED ACCORDING TO PROCEDURE #(B)(4) CORP PROC,BIOL EVALUATION. A GENERIC MATERIAL LIST IS PROVIDED IN # (B)(4) MATERIALS USED IN GN HEARING PRODUCTS. CASE INFORMATION STATES THAT END USER IS EXPERIENCING A REACTION IN RIGHT EAR ONLY WITH BOTH SILICONE AND ACRYLIC MATERIAL. ENT FOUND THAT RESULT OF A FUNGAL TEST SHOWED 'CANDIDA PARATSILOSIS' AND THAT SIMILAR SYMPTOMS ARE FOUND UNDER THE NOSE WHERE A SILICONE PART OF A CPAP MACHINE IS USED. THERE ARE MORE THAN 4000 KNOWN CHEMICALS WHO CAN ACT AS A CONTACT SENSITIZING CHEMICALS AND THE PROCESS OF CONTACT SENSITIZATION LASTS TYPICALLY WEEKS TO MONTHS. TO IDENTIFY A POTENTIAL REACTION TO THE DOME SILICONE MATERIAL, PATCH TESTING CAN BE A SOLUTION. ALTERNATIVE COUPLING STRATEGIES, SUCH AS A HYPOALLERGENIC MOULD COULD BE ATTEMPTED, IF THE ISSUE DOES NOT RESOLVE. CLINICAL CONCLUSION ON THE CASE IS THAT IT IS LIKELY THAT THE REACTION IS A REACTION TO THE HEARING AID DOMES. THE CONDITION HAS BEEN TREATED MEDICALLY AND NO FURTHER MEDICAL INTERVENTION WAS NEEDED. 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. RISK RELEVANT TO THIS CASE ARE ALREADY SPECIFIED IN THE RISK REGISTER POINTED ABOVE (0070600 GEN BTE & ITE RISK ANALYSIS) IN THE RISK ID U.1-8A: FAIL TO IDENTIFY HYPER-SENSITIVITY AND RISK ID OF B.1-1A BREACH OF BIOLOGIC SAFETY. THIS CASE IS CONSIDERED AS A SINGLE INCIDENT AND WILL BE INCLUDED IN REGULAR TRENDING. NO ACTIONS HAVE BEEN INITIATED BASED ON THIS INDIVIDUAL EVENT. NO FOLLOW UP INFORMATION IS CURRENTLY EXPECTED. THIS REPORT IS A COMBINED REPORT (INITIAL AND FINAL).
CLINICAL ASSESSMENT CONCLUSION THE CASE HAS BEEN REVIEWED FROM A CLINICAL PERSPECTIVE. CUSTOMER REPORTED: THEN END USER USED TO WEAR ACRYLIC EARMOLDS WHICH CAUSED PAIN AND BURNING IN RIGHT EAR; THE HCP SWITCHED TO SILICONE DOMES (TULIP) EM,RIE-HA-RF7-MPSF; END USER REPORTED EXPERIENCING IRRITATION, ITCHING, INFLAMMATION IN RIGHT EAR; THE ISSUE HAS NOT OCCURRED BEFORE; THE END USER REPORTED HAVING NO KNOWN ALLERGIES; THE END USERS WAS REFERRED TO ENT WHO FOUND THE REACTION TO BE A FUNGAL; INFECTION 'CANDIDA PARATSILOSIS' - THE SAME RESULTS "AS SOMEONE WHO WEARS PROSTHETICS"; END USER WAS TREATED WITH AN ANTI FUNGAL (TOPICAL AND ORAL); HCP REPORTED THAT PATIENT WEARS CPAP MACHINE AND HAS THE SAME IRRITATION UNDER HIS NOSE WHERE A SILICONE PORTION RUBS ON HIS SKIN.-THE END USER WAS RECOMMENDED TO STOP WEARING THE HEARING AIDS UNTIL A SOLUTION COULD E FOUND; THE HCP WILL INVESTIGATE ALTERNATIVE DOMES FROM OTHER MANUFACTURERS' (MATERIAL LISTS REQUESTED) TO TRY THEM OUT. CLINICAL EVALUATION OF THE EVENT: AS HEARING AIDS ARE DESIGNED TO HAVE SKIN CONTACT WITH THE END USER, THE MATERIALS USED IN THE HEARING AIDS ARE BIOCOMPATIBLE AND A BIOLOGICAL EVALUATED ACCORDING TO PROCEDURE #(B)(4) CORP PROC,BIOL EVALUATION. A GENERIC MATERIAL LIST IS PROVIDED IN #(B)(4) MATERIALS USED IN GN HEARING PRODUCTS. CASE INFORMATION STATES THAT END USER IS EXPERIENCING A REACTION IN RIGHT EAR ONLY WITH BOTH SILICONE AND ACRYLIC MATERIAL. ENT FOUND THAT RESULT OF A FUNGAL TEST SHOWED 'CANDIDA PARATSILOSIS' AND THAT SIMILAR SYMPTOMS ARE FOUND UNDER THE NOSE WHERE A SILICONE PART OF A CPAP MACHINE IS USED. THERE ARE MORE THAN 4000 KNOWN CHEMICALS WHO CAN ACT AS A CONTACT SENSITIZING CHEMICALS AND THE PROCESS OF CONTACT SENSITIZATION LASTS TYPICALLY WEEKS TO MONTHS. TO IDENTIFY A POTENTIAL REACTION TO THE DOME SILICONE MATERIAL, PATCH TESTING CAN BE A SOLUTION. ALTERNATIVE COUPLING STRATEGIES, SUCH AS A HYPOALLERGENIC MOULD COULD BE ATTEMPTED, IF THE ISSUE DOES NOT RESOLVE. CLINICAL CONCLUSION ON THE CASE IS THAT IT IS LIKELY THAT THE REACTION IS A REACTION TO THE HEARING AID DOMES. THE CONDITION HAS BEEN TREATED MEDICALLY AND NO FURTHER MEDICAL INTERVENTION WAS NEEDED. 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. RISK RELEVANT TO THIS CASE ARE ALREADY SPECIFIED IN THE RISK REGISTER POINTED ABOVE (0070600 GEN BTE & ITE RISK ANALYSIS) IN THE RISK ID U.1-8A: FAIL TO IDENTIFY HYPER-SENSITIVITY AND RISK ID OF B.1-1A BREACH OF BIOLOGIC SAFETY. THIS CASE IS CONSIDERED AS A SINGLE INCIDENT AND WILL BE INCLUDED IN REGULAR TRENDING. NO ACTIONS HAVE BEEN INITIATED BASED ON THIS INDIVIDUAL EVENT. NO TECHNICAL INVESTIGATION HAS BEEN DONE. THIS REPORT IS A FINAL REPORT. ON 21JUN2022, IT WAS REPORTED THAT THE PATIENT'S AGE IS NOT AVAILABLE.
(B)(4): IT WAS REPORTED- HCP REPORTS "ALLERGIC REACTION" AND "FUNGAL REACTION" TO SILICONE DOME (TULIP) AS WELL AS ACRYLIC EAR MOLD (SN: (B)(4). HCP REPORTS THAT THE PATIENT'S RIGHT EAR IS MUCH MORE SENSITIVE THAN THE LEFT EAR. HCP REPORTS THE PATIENT FIRST REPORTING AN ISSUE WITH THE ACRYLIC EM (B)(6) 2021("PAIN AND BURNING"). AT THAT TIME SHE DID NOT CALL IN BUT CHANGED THE EM TO A SILICONE TULIP DOME. SHE REFERRED ON TO ENT. HCP REPORTED THAT PATIENT STOPPED WEARING ANYTHING(I.E., DOME, EM) ON THE RIGHT SIDE AND HE HAS NOTICED SLIGHT IMPROVEMENT. JUST RECENTLY ENT SHARED WITH PATIENT THAT A FUNGAL TEST REVEALS THE SAME RESULTS "AS SOMEONE WHO WEARS PROSTHETICS". HCP SHARED THAT ENT STATED THE FUNGAL INFECTION WAS 'CANDIDA PARATSILOSIS'. HCP REPORTED THAT PATIENT WEARS CPAP MACHINE AND HAS THE SAME IRRITATION UNDER HIS NOSE WHERE A SILICONE PORTION RUBS ON HIS SKIN. SPOKE WITH VIKKI IN TFTS AS HCP INQUIRED ON WHAT WE CAN DO IF THIS PATIENT HAS AN ALLERGY TO SILICONE AND ACRYLIC. VIKKI RECOMMENDED THAT WE TRY AND DO A "MATTE FINISH" TO SEE IF THAT WERE ANY BETTER. HOWEVER- IT WAS EXPLAINED TO THE HCP AND THE PATIENT (AS HE WAS ON THE CALL) THAT THE UNDERLYING MATERIAL OF THE EM IS STILL IN FACT SILICONE. HCP STATED THAT THEY WOULD LIKE TO TRY IT. HCP ALSO ASKED WHAT WE WOULD SUGGEST ABOUT NOT WEARING A DOME/EM AT ALL AND ONLY THE RECEIVER. I ADVISED THAT WASN'T RECOMMENDED, FOR FEAR OF LOSING THE DEVICE, AND WOULD BE AT THE DISCRETION OF THE HCP/PATIENT. I HCP REQUESTED A "MATERIALS LIST" OF OUR SILICONE DOMES. I REQUESTED THIS MATERIAL LIST FROM MY LEAD, TAMMIEH. I SHARED WITH HCP THAT ONCE I RECEIVED IT I WOULD EMAIL IT TO HER. ISR NOTIFIED VIA EMAIL. COMPLAINT CREATED. (B)(6) 2022/AROY: INITIAL REPORTABILITY: HCP REPORTS "ALLERGIC REACTION" AND "FUNGAL REACTION" TO SILICONE DOME (TULIP) AS WELL AS ACRYLIC EAR MOLD (SN: (B)(4). THE CURRENT INFORMATION INDICATES NEED FOR IMMEDIATE REPORTING. ATTACHED REPORTING DECISION TREE SUPPORT THE REPORTABILITY DECISION. ON (B)(6) 2022 FOLLOW UP RECEIVED: PATIENT'S MEDICAL HISTORY OUTSIDE OF HIS EARS, BUT CANDIDA PARAPSILOSIS (FUNGAL) REACTION WAS IDENTIFIED BY HIS ENT. A REVIEW OF HIS AUDIOLOGY RECORDS SHOWS NO OTHER SIGNIFICANT MEDICAL HISTORY AND REPORTS OF DISCOMFORT BEGINNING RIGHT AFTER HIS FITTING (B)(6) 2020. (B)(6) 2022/AROY: FINAL REPORTABILITY: THE END USER USED TO WEAR ACRYLIC EARMOLDS WHICH CAUSED PAIN AND BURNING IN RIGHT EAR. THE HCP SWITCHED TO SILICONE DOMES (TULIP) EM,RIE-HA-RF7-MPSF . END USER REPORTED EXPERIENCING IRRITATION, ITCHING, INFLAMMATION IN RIGHT EAR. THE ISSUE HAS NOT OCCURRED BEFORE. THE END USER REPORTED HAVING NO KNOWN ALLERGIES. THE END USERS WAS REFERRED TO ENT WHO FOUND THE REACTION TO BE A FUNGAL INFECTION 'CANDIDA PARATSILOSIS' - THE SAME RESULTS "AS SOMEONE WHO WEARS PROSTHETICS". END USER WAS TREATED WITH AN ANTI-FUNGAL (TOPICAL AND ORAL). HCP REPORTED THAT PATIENT WEARS CPAP MACHINE AND HAS THE SAME IRRITATION UNDER HIS NOSE WHERE A SILICONE PORTION RUBS ON HIS SKIN. THE END USER WAS RECOMMENDED TO STOP WEARING THE HEARING AIDS UNTIL A SOLUTION COULD BE FOUND. THE HCP WILL INVESTIGATE ALTERNATIVE DOMES FROM OTHER MANUFACTURERS' (MATERIAL LISTS REQUESTED) TO TRY THEM OUT. CLINICAL EVALUATION OF THE EVENT: AS HEARING AIDS ARE DESIGNED TO HAVE SKIN CONTACT WITH THE END USER, THE MATERIALS USED IN THE HEARING AIDS ARE BIOCOMPATIBLE AND A BIOLOGICAL EVALUATED ACCORDING TO PROCEDURE # (B)(4) CORP PROC,BIOL EVALUATION. A GENERIC MATERIAL LIST IS PROVIDED IN #(B)(4) MATERIALS USED IN GN HEARING PRODUCTS. CASE INFORMATION STATES THAT END USER IS EXPERIENCING A REACTION IN RIGHT EAR ONLY WITH BOTH SILICONE AND ACRYLIC MATERIAL. ENT FOUND THAT RESULT OF A FUNGAL TEST SHOWED 'CANDIDA PARATSILOSIS' AND THAT SIMILAR SYMPTOMS ARE FOUND UNDER THE NOSE WHERE A SILICONE PART OF A CPAP MACHINE IS USED. THERE ARE MORE THAN 4000 KNOWN CHEMICALS WHO CAN ACT AS A CONTACT SENSITIZING CHEMICALS AND THE PROCESS OF CONTACT SENSITIZATION LASTS TYPICALLY WEEKS TO MONTHS. TO IDENTIFY A POTENTIAL REACTION TO THE DOME SILICONE MATERIAL, PATCH TESTING CAN BE A SOLUTION. ALTERNATIVE COUPLING STRATEGIES, SUCH AS A HYPOALLERGENIC MOULD COULD BE ATTEMPTED, IF THE ISSUE DOES NOT RESOLVE. CLINICAL CONCLUSION ON THE CASE IS THAT IT IS LIKELY THAT THE REACTION IS A REACTION TO THE HEARING AID DOMES. THE CONDITION HAS BEEN TREATED MEDICALLY AND NO FURTHER MEDICAL INTERVENTION WAS NEEDED. RISK REGISTER REFERENCE: RISK RELEVANT TO THIS CASE ARE ALREADY SPECIFIED IN THE RISK REGISTER POINTED ABOVE (0070600 GEN BTE & ITE RISK ANALYSIS) IN THE RISK ID U.1-8A: FAIL TO IDENTIFY HYPER-SENSITIVITY AND RISK ID OF B.1-1A BREACH OF BIOLOGIC SAFETY. BASED ON THE CLINICAL ASSESSMENT, AND RISK REGISTER INFORMATION THE CASE IS CONSIDERED REPORTABLE.:
(B)(4): IT WAS REPORTED- HCP REPORTS "ALLERGIC REACTION" AND "FUNGAL REACTION" TO SILICONE DOME (TULIP) AS WELL AS ACRYLIC EAR MOLD (SN: (B)(6)). HCP REPORTS THAT THE PATIENT'S RIGHT EAR IS MUCH MORE SENSITIVE THAN THE LEFT EAR. HCP REPORTS THE PATIENT FIRST REPORTING AN ISSUE WITH THE ACRYLIC EM (B)(6) 2021("PAIN AND BURNING"). AT THAT TIME SHE DID NOT CALL IN BUT CHANGED THE EM TO A SILICONE TULIP DOME. SHE REFERRED ON TO ENT. HCP REPORTED THAT PATIENT STOPPED WEARING ANYTHING(I.E., DOME, EM) ON THE RIGHT SIDE AND HE HAS NOTICED SLIGHT IMPROVEMENT. JUST RECENTLY ENT SHARED WITH PATIENT THAT A FUNGAL TEST REVEALS THE SAME RESULTS "AS SOMEONE WHO WEARS PROSTHETICS". HCP SHARED THAT ENT STATED THE FUNGAL INFECTION WAS 'CANDIDA PARATSILOSIS'. HCP REPORTED THAT PATIENT WEARS CPAP MACHINE AND HAS THE SAME IRRITATION UNDER HIS NOSE WHERE A SILICONE PORTION RUBS ON HIS SKIN. SPOKE WITH VIKKI IN TFTS AS HCP INQUIRED ON WHAT WE CAN DO IF THIS PATIENT HAS AN ALLERGY TO SILICONE AND ACRYLIC. VIKKI RECOMMENDED THAT WE TRY AND DO A "MATTE FINISH" TO SEE IF THAT WERE ANY BETTER. HOWEVER- IT WAS EXPLAINED TO THE HCP AND THE PATIENT(AS HE WAS ON THE CALL) THAT THE UNDERLYING MATERIAL OF THE EM IS STILL IN FACT SILICONE. HCP STATED THAT THEY WOULD LIKE TO TRY IT. HCP ALSO ASKED WHAT WE WOULD SUGGEST ABOUT NOT WEARING A DOME/EM AT ALL AND ONLY THE RECEIVER. I ADVISED THAT WASN'T RECOMMENDED, FOR FEAR OF LOSING THE DEVICE, AND WOULD BE AT THE DISCRETION OF THE HCP/PATIENT. I HCP REQUESTED A "MATERIALS LIST" OF OUR SILICONE DOMES. I REQUESTED THIS MATERIAL LIST FROM MY LEAD, TAMMIEH. I SHARED WITH HCP THAT ONCE I RECEIVED IT I WOULD EMAIL IT TO HER. ISR NOTIFIED VIA EMAIL. COMPLAINT CREATED. 10-MAY-2022: INITIAL REPORTABILITY: HCP REPORTS "ALLERGIC REACTION" AND "FUNGAL REACTION" TO SILICONE DOME (TULIP) AS WELL AS ACRYLIC EAR MOLD (SN: (B)(6)). THE CURRENT INFORMATION INDICATES NEED FOR IMMEDIATE REPORTING. ATTACHED REPORTING DECISION TREE SUPPORT THE REPORTABILITY DECISION. ON 27MAY2022 FOLLOW UP RECEIVED: PATIENT'S MEDICAL HISTORY OUTSIDE OF HIS EARS, BUT CANDIDA PARAPSILOSIS (FUNGAL) REACTION WAS IDENTIFIED BY HIS ENT. A REVIEW OF HIS AUDIOLOGY RECORDS SHOWS NO OTHER SIGNIFICANT MEDICAL HISTORY AND REPORTS OF DISCOMFORT BEGINNING RIGHT AFTER HIS FITTING (B)(6) 2020. 31MAY2022: FINAL REPORTABILITY: THE END USER USED TO WEAR ACRYLIC EARMOLDS WHICH CAUSED PAIN AND BURNING IN RIGHT EAR. THE HCP SWITCHED TO SILICONE DOMES (TULIP) EM,RIE-HA-RF7-MPSF . END USER REPORTED EXPERIENCING IRRITATION, ITCHING, INFLAMMATION IN RIGHT EAR. THE ISSUE HAS NOT OCCURRED BEFORE. THE END USER REPORTED HAVING NO KNOWN ALLERGIES. THE END USERS WAS REFERRED TO ENT WHO FOUND THE REACTION TO BE A FUNGAL INFECTION 'CANDIDA PARATSILOSIS' - THE SAME RESULTS "AS SOMEONE WHO WEARS PROSTHETICS". END USER WAS TREATED WITH AN ANTI-FUNGAL (TOPICAL AND ORAL). HCP REPORTED THAT PATIENT WEARS CPAP MACHINE AND HAS THE SAME IRRITATION UNDER HIS NOSE WHERE A SILICONE PORTION RUBS ON HIS SKIN. THE END USER WAS RECOMMENDED TO STOP WEARING THE HEARING AIDS UNTIL A SOLUTION COULD BE FOUND. THE HCP WILL INVESTIGATE ALTERNATIVE DOMES FROM OTHER MANUFACTURERS' (MATERIAL LISTS REQUESTED) TO TRY THEM OUT. THE CASE IS RESPORTABLE AS THE INJURY NECESSITATED MEDICAL INTERVENTION. 27JUN2022: PLEASE CONSIDER THIS IS A FINAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1599067 | GN RESOUND | HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY | OSM | GN HEARING A/S | EM,RIE-HA-RF7-MPSF | UNKNOWN | 05708296140275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |