ARTIC DENTURE TEETH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-05-21 for ARTIC DENTURE TEETH manufactured by Heraeus Kulzer, Gmbh.

Event Text Entries

[3463001] A dentist called to get info to help her patient determine what is causing his allergic reaction and what to do to help him. She said that she delivered a flipper to him on (b)(6) 2013. The flipper replaces teeth number 23, 24, and 25. She said that he used to have a pfm in this area. She said that the reaction is only on the lip and not on the ridge, tongue or other oral mucosa. She said that it is swollen, red and itchy. She said he was seeing a physician for the symptoms but she was not sure if he was taking any medication. She has advised him to stop wearing the flipper, but he wears it when he goes out as he has no teeth on the lower mandibular without it. She is hoping to find out what he might use to replace as most denture teeth are made from acrylic and he has been diagnosed as having allergies to different plastics since receiving the flipper. Asked if she knows if and what type of bonder and sealant were used on the flipper as well as the brand of acrylic denture base materials. She said she would find out what other materials were used. She said she had not thought of the sealer or bonder when considering allergens. She said that since other tissues had not reacted that she assumed it was the teeth. Recommended advising pt not to wear flipper at all as the reaction could worsen with continued exposure. She said she would advise the pt. She will get a list of other products used in the fabrication of the flipper. She will e-mail to me. I told her i would request an ingredients list for the teeth. On (b)(6) 2013, the dentist sid that the denture material used was (b)(4), but that she did not have info on the sealer or bonder used. She said that the pt is preparing to have an implant retained bridge placed after the bone graft heals. She did not have info on the type of graft material used. She has a list of products he has been confirmed as having an allergy to and she will email it to us. A list of ingredients for the teeth was provided. She will give this info to the allergists to see if he has been tested for an allergy on these materials. She already has a c2 artic tooth to give to the allergist if he decided to conduct further testing. On (b)(6) 2013, received via fax from the dentist; msds for (b)(4) yellow hi-shine polishing compound. She said that the lab did not use a bonder or sealant on the denture. She also faxed the t. R. U. E. Test allergy test results that were provided by the pt. The pt had at least 2 of the panels ran. She has not received a response after several calls to the allergist to get more info. The pt at least had panel 2. 2 and 3. 2 ran as he had positive results from each of these. Panel 2. 2 he had a positive result from the epoxy resin and from panel 3. 2 he had a positive result from gold sodium thiosulfate. She will call with any updates and we will continue to monitor patient's condition. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1925223-2013-00063
MDR Report Key3150532
Report Source99
Date Received2013-05-21
Date of Report2013-05-03
Date Facility Aware2013-05-03
Report Date2013-05-03
Date Added to Maude2013-06-07
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTIC DENTURE TEETH
Generic NameELM DENTURE, PLASTIC TEETH
Product CodeELM
Date Received2013-05-21
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER, GMBH
Manufacturer AddressDORMAGEN GM


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-05-21

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