BIOGLUE - UNKNOWN CONFIGURATION BG UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-26 for BIOGLUE - UNKNOWN CONFIGURATION BG UNK manufactured by Cryolife, Inc..

MAUDE Entry Details

Report Number1063481-2020-00002
MDR Report Key9882480
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-26
Date of Report2020-03-26
Date Facility Aware2020-03-04
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-26
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 ContactROCHELLE MANEY
Manufacturer Street1655 ROBERTS BLVD.
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal30144
Manufacturer Phone7704193355
Manufacturer G1CRYOLIFE, INC.
Manufacturer Street1655 ROBERTS BLVD. NW
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal Code30144
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOGLUE - UNKNOWN CONFIGURATION
Generic NameGLUE,SURGICAL, ARTERIES
Product CodeMUQ
Date Received2020-03-26
Model NumberBG UNK
Lot NumberUNKNOWN
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCRYOLIFE, INC.
Manufacturer Address1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-03-26

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