PACK, ECMO, DISPOSABLE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-04 for PACK, ECMO, DISPOSABLE * manufactured by Medtronic.

MAUDE Entry Details

Report Number2576652
MDR Report Key2576652
Date Received2012-05-04
Date of Report2011-03-25
Date of Event2011-03-17
Report Date2011-03-25
Date Reported to FDA2012-05-04
Date Added to Maude2012-05-16
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePACK, ECMO, DISPOSABLE
Generic NameFLOW PROBE
Product CodeDPT
Date Received2012-05-04
Model Number*
Catalog Number*
Lot Number10060109
ID Number*
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC
Manufacturer Address8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
10 2012-05-04

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