GENTLE CATH 421911

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-12-31 for GENTLE CATH 421911 manufactured by Unomedical S.r.o..

MAUDE Entry Details

Report Number3005778470-2019-00187
MDR Report Key9535767
Report SourceFOREIGN,USER FACILITY
Date Received2019-12-31
Date of Event2019-12-01
Date Mfgr Received2020-01-30
Date Added to Maude2019-12-31
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. JEANETTE JOHNSON
Manufacturer Street7900 TRIAD CENTER DRIVE SUITE 400
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3365424681
Manufacturer G1UNOMEDICAL S.R.O.
Manufacturer StreetPRIEMYSELNY PARK 3,
Manufacturer CityMICHALOVCE 07101
Manufacturer CountryLO
Manufacturer Postal Code07101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGENTLE CATH
Generic NameCATHETER, URETHRAL
Product CodeGBM
Date Received2019-12-31
Model Number421911
Lot Number8G00725
Device Expiration Date2019-12-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL S.R.O.
Manufacturer AddressPRIEMYSELNY PARK 3, MICHALOVCE 07101 LO 07101


Patients

Patient NumberTreatmentOutcomeDate
10 2019-12-31

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