BAG SET, 500ML, ENFITCONNECTOR INF0500-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-05 for BAG SET, 500ML, ENFITCONNECTOR INF0500-A manufactured by Moog Medical Devices Group.

MAUDE Entry Details

Report Number1722139-2019-00265
MDR Report Key8965677
Report SourceUSER FACILITY
Date Received2019-09-05
Date of Report2019-08-08
Date of Event2019-08-08
Date Mfgr Received2019-08-08
Device Manufacturer Date2019-03-02
Date Added to Maude2019-09-05
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 ContactKRISTIN HARDESTY
Manufacturer Street4314 ZEVEX PARK LANE
Manufacturer CitySALT LAKE CITY UT 84123
Manufacturer CountryUS
Manufacturer Postal84123
Manufacturer Phone8012641001
Manufacturer G1MOOG MEDICAL DEVICES GROUP, SRL
Manufacturer StreetCOYOL FREE ZONE AND BUSINESS PARK
Manufacturer CityALAJUELA, 20113
Manufacturer CountryCS
Manufacturer Postal Code20113
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBAG SET, 500ML, ENFITCONNECTOR
Generic NameENTERAL FEEDING SET
Product CodePIO
Date Received2019-09-05
Model NumberINF0500-A
Catalog NumberINF0500-A
Lot NumberCF1906103
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMOOG MEDICAL DEVICES GROUP
Manufacturer Address4314 ZEVEX PARK LANE SALT LAKE CITY UT 84123 US 84123


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-05

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