FOUNDATION 27-500-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-19 for FOUNDATION 27-500-100 manufactured by Olympus Terumo Biomaterials Corp. Mishima Factory.

MAUDE Entry Details

Report Number3007738819-2019-00005
MDR Report Key9857968
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-19
Date of Report2019-05-04
Date Mfgr Received2019-05-04
Device Manufacturer Date2014-09-19
Date Added to Maude2020-03-19
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. JIRO HIRAI
Manufacturer Street1-50-1 SASAZUKA,SHIBUYA-KU
Manufacturer CityTOKYO, 151-0073
Manufacturer CountryJA
Manufacturer Postal151-0073
Manufacturer G1OLYMPUS TERUMO BIOMATERIALS CORP.
Manufacturer Street1-50-1 SASAZUKA,SHIBUYA-KU
Manufacturer CityTOKYO, 151-0073
Manufacturer CountryJA
Manufacturer Postal Code151-0073
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFOUNDATION
Generic NameBONE GRAFTING MATERIAL, SYNTHETIC
Product CodeLYC
Date Received2020-03-19
Model Number27-500-100
Catalog Number27-500-100
Lot NumberM1407E
Device Expiration Date2017-06-30
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
Manufacturer Address454-1 HIGASHINO,NAGAIZUMI-CHO SUNTO-GUN SHIZUOKA, 411-0931 JA 411-0931


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

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