SPECTRA OPTIA 10400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-25 for SPECTRA OPTIA 10400 manufactured by Terumo Bct.

MAUDE Entry Details

Report Number1722028-2019-00314
MDR Report Key9238974
Date Received2019-10-25
Date of Report2019-10-25
Date of Event2019-10-01
Date Mfgr Received2019-11-15
Device Manufacturer Date2019-02-27
Date Added to Maude2019-10-25
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 ContactGARY DARK
Manufacturer Street10810 W. COLLINS AVE
Manufacturer CityLAKEWOOD CO 80215
Manufacturer CountryUS
Manufacturer Postal80215
Manufacturer Phone3035425102
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPECTRA OPTIA
Generic NameSPECTRA OPTIA PLATELET PLASMA
Product CodeLKN
Date Received2019-10-25
Catalog Number10400
Lot Number1902283330
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO BCT
Manufacturer AddressLAKEWOOD CO 80215 US 80215


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-10-25

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