URO170816S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-27 for URO170816S manufactured by Medline Industries Inc..

MAUDE Entry Details

Report Number1417592-2019-00102
MDR Report Key8739843
Date Received2019-06-27
Date of Report2019-06-27
Date of Event2019-05-25
Date Mfgr Received2019-05-30
Date Added to Maude2019-06-27
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 ContactBERMON PUNZALAN
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 60093
Manufacturer CountryUS
Manufacturer Postal60093
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Generic NameTTL1LYR 16FR10ML 100%SILI UMST TR
Product CodeOHR
Date Received2019-06-27
Catalog NumberURO170816S
Lot Number592180606
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-27

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