FOLEY CATHETER 81-080416

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-10-17 for FOLEY CATHETER 81-080416 manufactured by Deroyal Cientifica De Latinoamerica S.r.l..

MAUDE Entry Details

Report Number2320762-2019-00010
MDR Report Key9202211
Report SourceDISTRIBUTOR
Date Received2019-10-17
Date of Report2019-10-17
Date of Event2019-09-17
Date Mfgr Received2019-10-17
Date Added to Maude2019-10-17
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 ContactSARAH BENNETT
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653626112
Manufacturer G1DEROYAL INDUSTRIES, INC.
Manufacturer Street1595 HIGHWAY 33 SOUTH
Manufacturer CityNEW TAZEWELL TN 37825
Manufacturer CountryUS
Manufacturer Postal Code37825
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFOLEY CATHETER
Generic NameCATHETER, UPPER URINARY TRACT
Product CodeEYC
Date Received2019-10-17
Model Number81-080416
Lot Number49982535
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
Manufacturer AddressGLOBAL PARK, BOX 180-3006 602 PARKWAY, LA AURORA HEREDIA, HEREDIA 146 CS 146


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-17

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