SPECTRA OPTIA 10220

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-24 for SPECTRA OPTIA 10220 manufactured by Terumo Bct.

MAUDE Entry Details

Report Number1722028-2020-00132
MDR Report Key9872536
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2017-11-01
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-24
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 ContactSCOT HILDEN
Manufacturer Street10810 W. COLLINS AVE
Manufacturer CityLAKEWOOD CO 80215
Manufacturer CountryUS
Manufacturer Postal80215
Manufacturer Phone3032314970
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPECTRA OPTIA
Generic NameSPECTRA OPTIA EXCHANGE SET
Product CodeLKN
Date Received2020-03-24
Catalog Number10220
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-24

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