DYNJAPF6057A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-15 for DYNJAPF6057A manufactured by Medline Industries, Inc..

MAUDE Entry Details

Report Number9191259
MDR Report Key9191259
Date Received2019-10-15
Date of Report2019-09-20
Date of Event2019-09-18
Report Date2019-09-20
Date Reported to FDA2019-09-20
Date Reported to Mfgr2019-10-09
Date Added to Maude2019-10-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Product CodeCAI
Date Received2019-10-15
Model NumberDYNJAPF6057A
Catalog NumberDYNJAPF6057A
Lot Number19GB1659
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-15

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