UNOMETER SAFETI+HK 150CMTBNG LRL 1X10INT 413455

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-05-23 for UNOMETER SAFETI+HK 150CMTBNG LRL 1X10INT 413455 manufactured by Unomedical Zavodskaya Street 50.

Event Text Entries

[146238464] (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. Fda registration number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[146238465] It was reported that "the urine is retained in the proximal area proximal to the catheter and can not make its way to the drainage bag. The retention point is the white filter". Additional information was received clarifying the catheter connector is where the "white filter" is located within the product that caused "hinder urine". It is unclear as to how long the product was in use prior to noting the stated issue. Bladder ballooning was performed after the product was removed. No harm was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007966929-2019-00015
MDR Report Key8637978
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-05-23
Date of Event2019-05-03
Date Mfgr Received2019-05-03
Date Added to Maude2019-05-23
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 ZAVODSKAYA STREET 50
Manufacturer StreetFE UNOMEDICAL LTD MINSK REGION
Manufacturer CityMINSKAYA VOBLASTS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNOMETER SAFETI+HK 150CMTBNG LRL 1X10INT
Generic NameDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
Product CodeFFG
Date Received2019-05-23
Model Number413455
Lot Number202038
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL ZAVODSKAYA STREET 50
Manufacturer AddressFE UNOMEDICAL LTD MINSK REGION MINSKAYA VOBLASTS


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-23

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