INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR 98432 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-02-14 for INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR 98432 N/A manufactured by Avanos Medical Inc..

MAUDE Entry Details

Report Number9611594-2020-00028
MDR Report Key9712674
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2020-02-14
Date of Report2020-02-14
Date of Event2020-01-30
Date Mfgr Received2020-01-30
Device Manufacturer Date2018-04-11
Date Added to Maude2020-02-14
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 SA DE R.L. DE C.V. (AVENT 1)
Manufacturer StreetCIRCUITO INDUSTIAL NO.40 COLONIA OBRERA
Manufacturer CityNOGALES, CP 84048
Manufacturer CountryMX
Manufacturer Postal Code84048
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 20FR DILATOR
Generic NameDH EF PERC PLACEMENT PRODUCTS
Product CodeKGC
Date Received2020-02-14
Model Number98432
Catalog NumberN/A
Lot NumberAA8099R05
Device Expiration Date2020-02-01
Device AvailabilityY
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 2020-02-14

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