{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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THIS INCIDENT IS REPORTABLE ACCORDING TO 21 CFR 803. THE FDA DEFINES THIS AS A SERIOUS INJURY (21 CFR SEC. 803.3) AS THE OFFICE STAFF REPORTED THE EMPLOYEE HAVING AN ALLERGIC TYPE REACTION. THIS MATERIAL IS NOT SOLD IN THE USA. KULZER NORTH AMERICA DISTRIBUTES A COMPARABLE PRODUCT, WHERE THE INDICATIONS OF USE ARE THE SAME, HOWEVER THE CHEMISTRY IS DIFFERENT. THE INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. EMPLOYEES OF THE DEPARTMENT FOR PROCESSING DENTURE BASE MATERIALS COMPLAIN ABOUT MORE OR LESS OF MORE OR LESS SEVERE SYMPTOMS (ALLEGATION OF AN ALLERGY). THEY DESCRIBE DIFFERENT SYMPTOMS: ITCHY REDNESS BETWEEN THE FINGERS AND ON THE FOREARMS. IF PLASTIC IS USED UNDER THE GOWN, THERE WILL BE REDNESS HERE AS WELL. THE SYMPTOMS ARE PERSISTENT. THIS DENTAL TECHNICIAN HAS AN APPOINTMENT WITH AN ALLERGIST. ITCHING AND REDNESS ON THE FOREARMS, WHILE WORKING OUT, OF PALAXTREME. GO BACK IN THE EVENING. HAS BEEN BACK IN THE DEPARTMENT FOR 2 WEEKS NOW, HE COMPLAINS OF ECZEMA ON HIS LEFT HAND, WHICH IS PERMANENTLY OPEN. HANDS ALSO REDDENED AND ITCHING. THREE OTHERS ARE ON VACATION OR AT SCHOOL RIGHT NOW, THEY COMPLAIN ABOUT COMPARABLE SYMPTOMS. ON (B)(6) SENT THE COMPOSITION TO THE ALLERGIST. NORMALLY, THE PATIENT SHOULD NOT COME INTO DIRECT CONTACT WITH THE COMPONENTS, ESPECIALLY NOT ON THE ARMS, AS PERSONAL PROTECTIVE EQUIPMENT IN THE FORM OF GLOVES IS GENERALLY RECOMMENDED FOR PROCESSING. THERE HAS ALSO BEEN TALK ABOUT THE SUSPICION THAT THE REACTIONS COULD BE CAUSED BY THE SPLINTERS OR ABRASION, I.E. MECHANICAL IRRITATION. IT WOULD HAVE TO BE CLARIFIED ONCE AGAIN WHY THE EMPLOYEE COMES INTO CONTACT WITH THE SHAVERS AT ALL, SINCE THE PROCESSING AT THE DENTAL TECHNICIAN'S WORKPLACE SHOULD TAKE PLACE UNDER SUCTION AND SHOULD NOT ACTUALLY GET ON THE SKIN. 8/26/2020- THANKS FOR THE INFORMATION PROVIDED. I SPOKE WITH MS. (B)(6) TODAY AND REFERRED HER TO AN OCCUPATIONAL PHYSICIAN FOR FURTHER CLARIFICATION OF HER COMPLAINTS. WE EVALUATED IT TOXICOLOGICALLY WITH GREAT CARE, WITH SIGNIFICANTLY BETTER RESIDUAL MONOMER CONTENTS THAN PREVIOUSLY USUAL AND REQUIRED BY THE STANDARD. THE PRODUCT HAS BEEN ON THE MARKET SINCE SEPTEMBER LAST YEAR AND THIS IS THE FIRST CASE OF THIS KIND AND IT IS OF COURSE NOW NO INCOMPATIBILITY ISSUE IN A PATIENT. AND I SEE, LIKE YOU, THAT IT IS AN OCCUPATIONAL HEALTH ISSUE. ANYTHING THAT CAN HELP US TO UNDERSTAND THE SUBJECT AND EXPLAIN THE PROBLEM, WILL HELP US TO DO SOMETHING BASED ON IT OR TO CONSIDER OCCUPATIONAL HYGIENE PRECAUTIONS. 8/31/2020- THE DENTAL TECHNICIAN HAS AN APPOINTMENT WITH THE ON (B)(6) . THE ALLERGIST ASKED IF HE IS ALLOWED TO FORWARD THE OCCUPATIONAL PHYSICIAN. AE PERMITS TO GIVE THE COMPOSITION TO THE OCCUPATIONAL PHYSICIAN. ALLERGIST FORWARDED THE PRODUCT'S COMPOSITION TO THE OCCUPATIONAL PHYSICIAN AND ASKED HIM TO GIVE A FEEDBACK TO AE." }, { "mdr_text_key": "320710291", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THIS A FOLLOW UP TO CORRECT MANUFACTURER ENTERED ORIGINALLY. DENTAL TECHNICIAN SUFFERED FROM ITCHING AND REDNESS BETWEEN FINGERS AND FOREARMS DURING FABRICATION OF DENTURES USING PALAXTREME IN A LAB SETTING." }, { "mdr_text_key": "215909963", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THIS INCIDENT IS REPORTABLE ACCORDING TO 21 CFR 803. THE FDA DEFINES THIS AS A SERIOUS INJURY (21 CFR SEC. 803.3) AS THE OFFICE STAFF REPORTED THE EMPLOYEE HAVING AN ALLERGIC TYPE REACTION. THIS MATERIAL IS NOT SOLD IN THE USA. KULZER NORTH AMERICA DISTRIBUTES A COMPARABLE PRODUCT, WHERE THE INDICATIONS OF USE ARE THE SAME, HOWEVER THE CHEMISTRY IS DIFFERENT. THE INCIDENT WILL BE REPORTED TO MAINTAIN COMPLIANCE WITH 21 CFR 803 AND OUT OF AN ABUNDANCE OF CAUTION. EMPLOYEES OF THE DEPARTMENT FOR PROCESSING DENTURE BASE MATERIALS COMPLAIN ABOUT MORE OR LESS OF MORE OR LESS SEVERE SYMPTOMS (ALLEGATION OF AN ALLERGY). THEY DESCRIBE DIFFERENT SYMPTOMS: ITCHY REDNESS BETWEEN THE FINGERS AND ON THE FOREARMS. IF PLASTIC IS USED UNDER THE GOWN, THERE WILL BE REDNESS HERE AS WELL. THE SYMPTOMS ARE PERSISTENT. THIS DENTAL TECHNICIAN HAS AN APPOINTMENT WITH AN ALLERGIST. ITCHING AND REDNESS ON THE FOREARMS, WHILE WORKING OUT, OF PALAXTREME. GO BACK IN THE EVENING. HAS BEEN BACK IN THE DEPARTMENT FOR 2 WEEKS NOW, HE COMPLAINS OF ECZEMA ON HIS LEFT HAND, WHICH IS PERMANENTLY OPEN. HANDS ALSO REDDENED AND ITCHING. THREE OTHERS ARE ON VACATION OR AT SCHOOL RIGHT NOW, THEY COMPLAIN ABOUT COMPARABLE SYMPTOMS. ON (B)(6), (B)(6) SENT THE COMPOSITION TO THE ALLERGIST. NORMALLY, THE PATIENT SHOULD NOT COME INTO DIRECT CONTACT WITH THE COMPONENTS, ESPECIALLY NOT ON THE ARMS, AS PERSONAL PROTECTIVE EQUIPMENT IN THE FORM OF GLOVES IS GENERALLY RECOMMENDED FOR PROCESSING. THERE HAS ALSO BEEN TALK ABOUT THE SUSPICION THAT THE REACTIONS COULD BE CAUSED BY THE SPLINTERS OR ABRASION, I.E. MECHANICAL IRRITATION. IT WOULD HAVE TO BE CLARIFIED ONCE AGAIN WHY THE EMPLOYEE COMES INTO CONTACT WITH THE SHAVERS AT ALL, SINCE THE PROCESSING AT THE DENTAL TECHNICIAN'S WORKPLACE SHOULD TAKE PLACE UNDER SUCTION AND SHOULD NOT ACTUALLY GET ON THE SKIN. ON (B)(6) 2020- THANKS FOR THE INFORMATION PROVIDED. I SPOKE WITH MS. A TODAY AND REFERRED HER TO AN OCCUPATIONAL PHYSICIAN FOR FURTHER CLARIFICATION OF HER COMPLAINTS. WE EVALUATED IT TOXICOLOGICALLY WITH GREAT CARE, WITH SIGNIFICANTLY BETTER RESIDUAL MONOMER CONTENTS THAN PREVIOUSLY USUAL AND REQUIRED BY THE STANDARD. THE PRODUCT HAS BEEN ON THE MARKET SINCE SEPTEMBER LAST YEAR AND THIS IS THE FIRST CASE OF THIS KIND AND IT IS OF COURSE NOW NO INCOMPATIBILITY ISSUE IN A PATIENT. AND I SEE, LIKE YOU, THAT IT IS AN OCCUPATIONAL HEALTH ISSUE. ANYTHING THAT CAN HELP US TO UNDERSTAND THE SUBJECT AND EXPLAIN THE PROBLEM, WILL HELP US TO DO SOMETHING BASED ON IT OR TO CONSIDER OCCUPATIONAL HYGIENE PRECAUTIONS. ON (B)(6) 2020- THE DENTAL TECHNICIAN HAS AN APPOINTMENT WITH THE ON (B)(6). THE ALLERGIST ASKED IF HE IS ALLOWED TO FORWARD THE OCCUPATIONAL PHYSICIAN. AE PERMITS TO GIVE THE COMPOSITION TO THE OCCUPATIONAL PHYSICIAN. ALLERGIST FORWARDED THE PRODUCT'S COMPOSITION TO THE OCCUPATIONAL PHYSICIAN AND ASKED HIM TO GIVE A FEEDBACK TO AE." }, { "mdr_text_key": "215909964", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DENTAL TECHNICIAN SUFFERED FROM ITCHING AND REDNESS BETWEEN FINGERS AND FOREARMS DURING FABRICATION OF DENTURES USING PALAXTREME IN A LAB SETTING." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/14/2020" } ] }