ALGINATE BASIS 776-2102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-12 for ALGINATE BASIS 776-2102 manufactured by Ormco Corporation.

Event Text Entries

[139827343] It was alleged that a piece of metal was found in a 25lb. Bag of alginate. There was no serious injury associated with this incident.
Patient Sequence No: 1, Text Type: N, H10


[139827344] Customer found a metal piece in their alginate upon opening the bag.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2016150-2019-00005
MDR Report Key8333197
Date Received2019-02-12
Date of Report2019-05-20
Date of Event2019-01-18
Date Mfgr Received2019-01-18
Date Added to Maude2019-02-12
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 ContactMRS. SUZETTE RAMPAIR-JOHNSON
Manufacturer Street1889 W. MISSION BLVD
Manufacturer CityPOMONA CA 91766
Manufacturer CountryUS
Manufacturer Postal91766
Manufacturer Phone9096713431
Manufacturer G1KERR CORPORATION
Manufacturer Street1889 W. MISSION BLVD
Manufacturer CityPOMONA CA 91766
Manufacturer CountryUS
Manufacturer Postal Code91766
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameALGINATE BASIS
Generic NameMATERIAL IMPRESSION
Product CodeELW
Date Received2019-02-12
Catalog Number776-2102
Lot Number6880196
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerORMCO CORPORATION
Manufacturer Address1889 W. MISSION BLVD POMONA CA 91766 US 91766


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-12

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