INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR 98431 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-02-26 for INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR 98431 N/A manufactured by Avanos Medical Inc..

MAUDE Entry Details

Report Number9611594-2020-00034
MDR Report Key9756653
Report SourceDISTRIBUTOR,FOREIGN,OTHER
Date Received2020-02-26
Date of Report2020-03-13
Date of Event2020-01-14
Date Mfgr Received2020-03-02
Device Manufacturer Date2016-01-10
Date Added to Maude2020-02-26
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, 18FR DILATOR
Generic NameDH EF PERC PLACEMENT PRODUCTS
Product CodeKGC
Date Received2020-02-26
Returned To Mfg2020-03-02
Model Number98431
Catalog NumberN/A
Lot NumberAA8008R04
Device Expiration Date2019-11-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAVANOS MEDICAL INC.
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-26

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