TYTIN 29949

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-08 for TYTIN 29949 manufactured by Kerr Corporation.

Event Text Entries

[110924964] No patient information in regards to age, weight, sex, ethnicity, and race was provided. An evaluation of the product is expected but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10


[110924965] An alleged complaint was reported that a doctor discovered some capsules have no mercury pillow pack and some capsules have two mercury pillow packs over several years. The doctor is concerned about the capsules with more than one pillow pack and the effect that it is having on the patient's restorations.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1815757-2018-00003
MDR Report Key7584018
Date Received2018-06-08
Date of Report2018-06-08
Date Mfgr Received2018-06-08
Device Manufacturer Date2015-04-02
Date Added to Maude2018-06-08
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 FDA3
Event Location3
Manufacturer ContactMR. PAULO CALLE
Manufacturer Street1717 W COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167752
Manufacturer G1KERR CORPORATION
Manufacturer Street28200 WICK ROAD
Manufacturer CityROMULUS MI 48174
Manufacturer CountryUS
Manufacturer Postal Code48174
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTYTIN
Generic NameDENTAL AMALGAM CAPSULE
Product CodeEJJ
Date Received2018-06-08
Catalog Number29949
Lot Number5-1092
OperatorDENTIST
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKERR CORPORATION
Manufacturer Address28200 WICK ROAD ROMULUS MI 48174 US 48174


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-08

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