8 GAL NDL DISP CONT YELLOW 10 8980Y

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-09 for 8 GAL NDL DISP CONT YELLOW 10 8980Y manufactured by Covidien.

MAUDE Entry Details

Report Number1424643-2019-00540
MDR Report Key8772363
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-09
Date of Report2019-10-04
Date of Event2019-06-28
Date Mfgr Received2019-06-28
Date Added to Maude2019-07-09
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer Street815 TEK DRIVE
Manufacturer CityCRYSTAL LAKE IL 600399002
Manufacturer CountryUS
Manufacturer Postal Code600399002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name8 GAL NDL DISP CONT YELLOW 10
Generic NameCONTAINER, SHARPS
Product CodeMMK
Date Received2019-07-09
Model Number8980Y
Catalog Number8980Y
Lot Number18E18663
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address815 TEK DRIVE CRYSTAL LAKE IL 600399002 US 600399002


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-09

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