UROPASS AS 11/13FR X 38 CM 5/BX 61138BX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-17 for UROPASS AS 11/13FR X 38 CM 5/BX 61138BX manufactured by Teleflex Medical Oem.

MAUDE Entry Details

Report Number2951238-2019-01013
MDR Report Key8798245
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-17
Date of Report2019-08-20
Date of Event2019-06-13
Date Mfgr Received2019-07-30
Date Added to Maude2019-07-17
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 ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUROPASS AS 11/13FR X 38 CM 5/BX
Generic NameUROPASS ACCESS SHEATH
Product CodeKNY
Date Received2019-07-17
Returned To Mfg2019-07-15
Model Number61138BX
Lot Number09M1800034
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL OEM
Manufacturer Address3750 ANNAPOLIS LANE NORTH, SUITE 160 PLYMOUTH MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-17

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