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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PALAXTREME, 500ML IT/ES/PT/GR; RESIN, DENTURE, RELINING, REPAIRING, REBASIN
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PALAXTREME, 500ML IT/ES/PT/GR; RESIN, DENTURE, RELINING, REPAIRING, REBASIN Back to Search Results
Catalog Number 66070958
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)
Event Type  Injury  
Manufacturer Narrative
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 patient having an allergic type reaction.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.The patient had upper and lower dentures made with the material palaxtreme in (b)(6) 2020, patient informed the dentist in (b)(6) 2021 of redness and itching throughout the mouth.Was prescribed an anti-fungal and antibiotic medication.The symptoms did not subside to date.Allergy testing has not been conducted at this point.A similar product sold in the usa contains these same ingredients (methyl-methacrylate).We as manufacturer could not clarify if our product is really the root cause of the described reaction; a lot of reasons are possible like confirmed allergies to certain alloys as well as residual monomer as well as hygenic issues of the patient in cleaning and handling of the prosthesis.We as manufacturer see this just as a prophylactic mdr without an established root cause and just due to an assumption of the importer of a similar root cause to other imported, similar denture base materials.Due to technical issues with webtrader this document could not be up-loaded before.Certificate issues hold back the access.Further difficulties arise from up-dating esubmitter software.
 
Event Description
Patient had lower and upper dentures seated in (b)(6) 2020.The patient complained about redness and itching in her mouth in (b)(6) 2020.The dental office reported this issue to kulzer on (b)(6) 2021.The patient was prescribed antibiotics and antifungal medication but did not see any improvement.Allergy testing on methyl-methacrylate is planned but took not yet place.The cooperation of lab and patient is very limited.In former allergy test an allergy to verious metals has been determined.
 
Event Description
Patient had lower and upper dentures seated in (b)(6) 2020.The patient complained about redness and itching in her mouth in (b)(6) 2020.The dental office reported this issue to kulzer on (b)(6) 2021.The patient was prescribed antibiotics and antifungal medication but did not see any improvement.Allergy testing on methyl-methacrylate is planned but took not yet place.The cooperation of lab and patient is very limited.In former allergy test an allergy to verious metals has been determined.
 
Manufacturer Narrative
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 patient having an allergic type reaction.The incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.The patient had upper and lower dentures made with the material palaxtreme in (b)(6) 2020, patient informed the dentist in (b)(6) 2021 of redness and itching throughout the mouth.Was prescribed an anti-fungal and antibiotic medication.The symptoms did not subside to date.Allergy testing has not been conducted at this point.A similar product sold in the usa contains these same ingredients (methyl-methacrylate).We as manufacturer could not clarify if our product is really the root cause of the described reaction; a lot of reasons are possible like confirmed allergies to certain alloys as well as residual monomer as well as hygienic issues of the patient in cleaning and handling of the prosthesis.We as manufacturer see this just as a prophylactic mdr without an established root cause and just due to an assumption of the importer of a similar root cause to other imported, similar denture base materials.Follow-up: on 9/23/2021 updated information was given.Allergy testing confirmed that the patient is not allergic to palaxtreme.
 
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Brand Name
PALAXTREME, 500ML IT/ES/PT/GR
Type of Device
RESIN, DENTURE, RELINING, REPAIRING, REBASIN
MDR Report Key12280114
MDR Text Key265147217
Report Number3005665377-2021-00007
Device Sequence Number1
Product Code EBI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number66070958
Date Manufacturer Received05/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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