INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR 98433 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-27 for INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR 98433 UNKNOWN manufactured by Avanos Medical Inc..

MAUDE Entry Details

Report Number3006646024-2019-00035
MDR Report Key9523210
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-12-27
Date of Report2020-03-06
Date Mfgr Received2020-02-12
Device Manufacturer Date2019-06-19
Date Added to Maude2019-12-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LISA CLARK
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485444
Manufacturer G1AVENT, INC.
Manufacturer Street6620 S. MEMORIAL PLACE SUITE 100
Manufacturer CityTUCSON AZ 85756
Manufacturer CountryUS
Manufacturer Postal Code85756
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 22FR DILATOR
Generic NameDH EF PEG INITIAL PLACEMENT PRODUCTS
Product CodeKGC
Date Received2019-12-27
Model Number98433
Catalog NumberUNKNOWN
Lot NumberAA9168R04
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAVANOS MEDICAL INC.
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-27

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