MAUDE Adverse Event Report: PALAXTREME, 500ML IT/ES/PT/GR; RESIN, DENTURE, RELINING, REPAIRING, REBASIN, PRODUCT CODE: EBI

Catalog Number 66070958

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Date 05/25/2021

Event Type  Injury  

Event Description

Patient had lower and upper dentures seated in (b)(6) 2020.The patient complained about redness and itching in her mouth in march 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 may or may not occur.

Event Description

Patient had lower and upper dentures seated on (b)(6) 2020.The patient complained about redness and itching in her mouth on (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 may or may not occur.10/19/2021- follow up report.On (b)(6) 2021, updated information was given.Allergy testing confirmed that the patient is not allergic to palaxtreme.

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 on (b)(6) 2020, patient informed the dentist on (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, it is unknown if it will be completed.A similar product sold in the usa contains these same ingredients.

• Brand Name: PALAXTREME, 500ML IT/ES/PT/GR
• Type of Device: RESIN, DENTURE, RELINING, REPAIRING, REBASIN, PRODUCT CODE: EBI
• MDR Report Key: 12051837
• MDR Text Key: 258095453
• Report Number: 1821514-2021-00008
• Device Sequence Number: 1
• Product Code: EBI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 06/22/2021,06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66070958
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Event Location: Other
• Date Report to Manufacturer: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other