MONDIAL 6-DEVICE 2 B2/L362 66017032

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-06-05 for MONDIAL 6-DEVICE 2 B2/L362 66017032 manufactured by Heraeus Kulzer Gmbh.

Event Text Entries

[2831672] This is the second of four reports on four style of teeth used on one denture. Reported to dentist (b)(6) 2012, after all symptoms resolved. On (b)(6) 2012, (b)(6) called because a patient thinks she is allergic to the new denture. On (b)(6) 2012, spoke to (b)(6). He said that the dentist called him to find out what was used in the denture. The patient stated she was allergic to her new denture. The dentist has not seen her. He said she told the dentist that she was going to the hospital, but did not. She is now wearing her old denture. He said he used mondial 6 b2, o 457, l362, mondial 8 b2 35 u an l. He also used a dentsply acrylic lucitone 199 dark pink. He said he did not use a sealant. I asked for the dentist information so that i could speak to him. Spoke to dr. (b)(6). He said that the patient had an old denture made of lucitone 199 dark pink and ipn teeth. He said that she wore those teeth for many years. He said that she called him a few weeks ago to let him know she had recently recovered from a rash with swelling of the mouth and throat. He said he assumed she had seen a physician for this and that she reported she almost had to go to the hospital. He said that she stopped wearing the new denture and returned to the old denture. He said she had a known allergy to plastic, but did not know if that meant all. I told him that it was highly improbable to be the teeth, as it is a type of plastic that does not have free monomer. I discussed that when the patient received the first denture, that she was not allergic, but has since developed an allergy. I told him that over the years the denture has lost its free monomer and thus, would not cause a reaction as the new denture base would, as it has free monomer. He said that he would discuss this with the patient, but that he was not willing to rule out the teeth. She is supposed to take the new denture to an allergist for allergy testing. I gave him my contact information and asked that we stay in contact. He said he would appreciate that. On (b)(6) 2012, spoke to (b)(6). I told her i called to follow up on the patient who had the trouble after receiving her new denture. She said she would ask dr. (b)(6). She came back and said that dr. (b)(6) was waiting to hear back from the allergist, but had no other news to give.
Patient Sequence No: 1, Text Type: D, B5


[10068925] (b)(4) (the importer) is submitting the report on behalf of heraeus kulzer (b)(4) (the manufacturer). Although we have not established that the device caused or contributed to the event, we're reporting it out of caution to be compliant with 21 cfr part 803. We cannot rule out causality. This is not the patient first denture. This is at least her second denture, she may have had previous relining or rebasing. There might have occurred a certain sensitization to mma on these occasions. When gets a new denture she suddenly has an allergic reaction. If a heat curing denture base material like lucitone 199 is well polymerized, it still shows a residual mma-content of about (b)(4). This mma is well locked inside the material and does not easily leak out. There is a large contact area for the denture base to the oral mucosa and some potential accumulation of residual mma-content in the contact area especially at the initial use. Unlike a denture base material which is processed under lab conditions, artificial teeth like mondial are manufactured under well controlled industrial conditions and show mma-content of significantly less than (b)(4). Additionally the contact to mucosa is limited. Mondial was introduced to market in 2004. There has been no evidence of allergic reactions with mondial. Biocompatibility tests done with mondial teeth support this very positive experience. Therefore our conclusion must be that the allergic reaction of the customer is not related to mondial, but more likely to the denture base material used for fabricating the denture.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9681707-2012-00004
MDR Report Key2657679
Report Source00,05
Date Received2012-06-05
Date of Report2012-05-07
Date of Event2012-02-29
Date Facility Aware2012-05-07
Report Date2012-06-04
Date Mfgr Received2012-05-08
Date Added to Maude2012-07-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactAUDRA BOGUCKI, RDH
Manufacturer Street300 HERAEUS WAY
Manufacturer CitySOUTH BEND IN 46614
Manufacturer CountryUS
Manufacturer Postal46614
Manufacturer Phone5742995409
Manufacturer G1HERAEUS KULZER GMBH
Manufacturer StreetALTE HEERSTRASSE/B 802
Manufacturer CityDORMAGEN 41538
Manufacturer CountryGM
Manufacturer Postal Code41538
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMONDIAL 6-DEVICE 2
Generic NameELM DENTURE, PLASTIC, TEETH
Product CodeELM
Date Received2012-06-05
Model NumberB2/L362
Catalog Number66017032
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age3 MO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER GMBH
Manufacturer AddressDORMAGEN GM


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-06-05

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