INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE 98432 109843200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2019-08-26 for INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE 98432 109843200 manufactured by Avanos Medical Inc..

MAUDE Entry Details

Report Number9611594-2019-00163
MDR Report Key8930875
Report SourceDISTRIBUTOR,USER FACILITY
Date Received2019-08-26
Date of Report2019-10-07
Date Mfgr Received2019-10-01
Device Manufacturer Date2018-07-17
Date Added to Maude2019-08-26
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 ContactMS. LISA CLARK
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485444
Manufacturer G1AVENT SA DE R.L. DE C.V. (AVENT 1)
Manufacturer StreetCIRCUITO INDUSTIAL NO.40 COLONIA OBRERA
Manufacturer CityNOGALES, CP
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE
Generic NameDH EF PERC PLACEMENT PRODUCTS
Product CodeKGC
Date Received2019-08-26
Model Number98432
Catalog Number109843200
Lot NumberAA8197R02
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 2019-08-26

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