SPECTRIS SOLARIS SYRINGE KIT 60728591 SSQK 65/115VS

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 2020-01-15 for SPECTRIS SOLARIS SYRINGE KIT 60728591 SSQK 65/115VS manufactured by Bayer Medical Care, Inc..

MAUDE Entry Details

Report Number2520313-2020-00002
MDR Report Key9591988
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-15
Date of Report2020-01-15
Date of Event2019-12-27
Date Mfgr Received2020-01-03
Device Manufacturer Date2019-05-21
Date Added to Maude2020-01-15
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 ContactSUSAN SHERWIN
Manufacturer Street1 BAYER DRIVE
Manufacturer CityINDIANOLA PA 15051
Manufacturer CountryUS
Manufacturer Postal15051
Manufacturer Phone7249408678
Manufacturer G1BAYER MEDICAL CARE, INC.
Manufacturer Street1 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 Received2020-01-15
Returned To Mfg2020-01-13
Model Number60728591
Catalog NumberSSQK 65/115VS
Lot Number200416
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAYER MEDICAL CARE, INC.
Manufacturer Address1 BAYER DRIVE INDIANOLA PA 15051 US 15051


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-15

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