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 8-DEVICE 3 B2 / 35U 66017357 manufactured by Heraeus Kulzer Gmbh.
[15508118]
This is the third 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 pt 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 pt 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 info so that i could speak to him. Spoke to dr (b)(6). He said that the pt 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 is 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 pt 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 pt, 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 info 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 pt 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
[15652796]
(b)(4) is submitting the report on behalf of heraeus kulzer (b)(4) (the mfr). Although we have not established that the device caused or contributed to the event, we're reporting it out of caution to be complaint with 21 cfr part 803. We cannot rule out causality. This is not the pt 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 leaking 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 mfg 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
| Report Number | 9681707-2011-00005 |
| MDR Report Key | 2619865 |
| Report Source | 00,05 |
| Date Received | 2012-06-05 |
| Date of Report | 2012-05-07 |
| Date of Event | 2012-02-29 |
| Date Facility Aware | 2012-05-07 |
| Report Date | 2012-06-04 |
| Date Mfgr Received | 2012-05-08 |
| Date Added to Maude | 2012-06-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | AUDRA BOGUCKI, RDH |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER GMBH |
| Manufacturer Street | ALTE HEERSTRASSW GEB B802 |
| Manufacturer City | DORMAGEN 41538 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 41538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONDIAL 8-DEVICE 3 |
| Generic Name | ELM DENTURE, PLASTIC, TEETH |
| Product Code | ELM |
| Date Received | 2012-06-05 |
| Model Number | B2 / 35U |
| Catalog Number | 66017357 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | DORMAGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-05 |