DYNJAA247

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for DYNJAA247 manufactured by Medline Industries Inc..

MAUDE Entry Details

Report Number1417592-2020-00030
MDR Report Key9857665
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-19
Date of Report2020-03-19
Date of Event2020-02-20
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-19
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 ContactKAREN TRUTSCH
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD, IL
Manufacturer CountryUS
Manufacturer Phone6434960
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NamePRIMARY ADULT INTUBATION KIT
Product CodeCAI
Date Received2020-03-19
Catalog NumberDYNJAA247
Lot Number19182386
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD, IL US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.