OSFERION 60A3

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 OSFERION 60A3 manufactured by Olympus Terumo Biomaterials Corp. Mishima Factory.

MAUDE Entry Details

Report Number3007738819-2019-00010
MDR Report Key9857975
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-19
Date of Report2019-10-17
Date Mfgr Received2019-10-17
Device Manufacturer Date2019-02-07
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
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 NameOSFERION
Generic NameFILLER, BONE VOID, CALCIUM COMPOUND
Product CodeMQV
Date Received2020-03-19
Catalog Number60A3
Lot NumberM18905C486
OperatorHEALTH PROFESSIONAL
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
101. Required No Informationntervention 2020-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.