CANGAROO ENVELOPE CMCV-009-XXL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-09 for CANGAROO ENVELOPE CMCV-009-XXL manufactured by Aziyo Biologics, Inc..

MAUDE Entry Details

Report Number3005619880-2020-00023
MDR Report Key9808668
Report SourceOTHER
Date Received2020-03-09
Date of Report2020-03-09
Date of Event2020-02-10
Date Mfgr Received2020-02-14
Device Manufacturer Date2019-09-06
Date Added to Maude2020-03-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ANDREW GREEN
Manufacturer Street1100 OLD ELLIS ROAD STE 1200
Manufacturer CityROSWELL, GA
Manufacturer CountryUS
Manufacturer G1AZIYO BIOLOGICS, INC.
Manufacturer Street1100 OLD ELLIS ROAD STE 1200
Manufacturer CityROSWELL, GA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCANGAROO ENVELOPE
Generic NameMESH, SURGICAL
Product CodeFTM
Date Received2020-03-09
Model NumberCMCV-009-XXL
Lot NumberM19K1381505
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAZIYO BIOLOGICS, INC.
Manufacturer Address1100 OLD ELLIS ROAD STE 1200 ROSWELL, GA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-09

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