SPECTRIS SOLARIS SYRINGE KIT 85233084 SSQK 115

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-15 for SPECTRIS SOLARIS SYRINGE KIT 85233084 SSQK 115 manufactured by Bayer Medical Care Inc..

MAUDE Entry Details

Report Number2520313-2019-00054
MDR Report Key9327511
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-15
Date of Report2019-11-15
Date of Event2019-11-07
Date Mfgr Received2019-11-07
Device Manufacturer Date2019-08-07
Date Added to Maude2019-11-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LOIS MILLER
Manufacturer StreetONE BAYER DRIVE
Manufacturer CityINDIANOLA PA 15051
Manufacturer CountryUS
Manufacturer Postal15051
Manufacturer Phone7249407497
Manufacturer G1BAYER MEDICAL CARE INC.
Manufacturer StreetONE BAYER DRIVE
Manufacturer CityINDIANOLA PA 15051
Manufacturer CountryUS
Manufacturer Postal Code15051
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPECTRIS SOLARIS SYRINGE KIT
Generic NameANGIOGRAPHIC SYRINGE KIT
Product CodeDXT
Date Received2019-11-15
Model Number85233084
Catalog NumberSSQK 115
Lot Number8411737
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAYER MEDICAL CARE INC.
Manufacturer AddressONE BAYER DRIVE INDIANOLA PA 15051 US 15051


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-15

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