ARTIC DENTURE TEETH

MAUDE Adverse Event Report

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

Event Text Entries

[16752648] Imp ref #(b)(4).
Patient Sequence No: 1, Text Type: D, B5


[16998758] As allowed by exemption #(b)(4), (the importer) is submitting the report on behalf of (b)(4) (the manufacturer). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9681707-2013-00005
MDR Report Key3150529
Report Source05
Date Received2013-05-21
Date Mfgr Received2013-05-03
Date Added to Maude2013-06-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactAUDI 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 NameARTIC DENTURE TEETH
Generic NameELM DENTURE, PLASTIC TEETH
Product CodeELM
Date Received2013-05-21
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHERAEUS KULZER GMBH
Manufacturer AddressDORMAGEN GM


Patients

Patient NumberTreatmentOutcomeDate
10 2013-05-21

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