KATETERVEN.CV.MONT.SL.1-25-100 90 804 1S-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-11-05 for KATETERVEN.CV.MONT.SL.1-25-100 90 804 1S-10 manufactured by Unomedical S.r.o..

Event Text Entries

[30488407] Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4). Convatec is submitting this report pursuant to the provisions of 21 cfr part 803. Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).
Patient Sequence No: 1, Text Type: N, H10


[30488408] It was reported that the valve leaks.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005778470-2015-31201
MDR Report Key5204242
Report SourceFOREIGN
Date Received2015-11-05
Date of Report2014-02-27
Date Mfgr Received2014-02-27
Date Added to Maude2015-11-05
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 ContactJEANETTE JOHNSON
Manufacturer Street211 AMERICAN AVE
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone3362973009
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKATETERVEN.CV.MONT.SL.1-25-100
Generic NameCONNECTOR, CATHETER
Product CodeGCD
Date Received2015-11-05
Returned To Mfg2014-02-25
Model Number90 804 1S-10
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL S.R.O.
Manufacturer AddressPRIEMYSELNY PARK 3 MICHALOVCE 07101 LO 07101


Patients

Patient NumberTreatmentOutcomeDate
10 2015-11-05

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