ENTERAL ACCESS DILATION SYSTEM 98703 109870301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-09-26 for ENTERAL ACCESS DILATION SYSTEM 98703 109870301 manufactured by Avanos Medical Inc..

MAUDE Entry Details

Report Number9611594-2019-00181
MDR Report Key9126463
Report SourceHEALTH PROFESSIONAL,OTHER,USE
Date Received2019-09-26
Date of Report2019-11-04
Date Mfgr Received2019-10-09
Date Added to Maude2019-09-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
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 NameENTERAL ACCESS DILATION SYSTEM
Generic NameDH EF PERC PLACEMENT PRODUCTS
Product CodeKGC
Date Received2019-09-26
Model Number98703
Catalog Number109870301
Lot NumberUNKNOWN
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
101. Required No Informationntervention 2019-09-26

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