TBD 158101010190

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 2020-02-21 for TBD 158101010190 manufactured by Unomedical Zavodskaya Street 50.

Event Text Entries

[183770586] Mdr3007966929-2020-00007 / device 1 of 1. Brand name: urine meter. Common device name: urine flow or volume measuring system. (b)(6). Date of manufacture: 02/2019. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[183770587] It was reported that the product caused a "bladder globe due to failed urine outflow. Due to this patient referred abdominal pain. " upon clarification a bladder globe is "an abnormal distension of the bladder due to the increase in the volume of urine contained therein secondary to acute urinary retention. The bladder globe is associated with suprapubic pain and reduced bladder contractility". It was reported by the user facility that the patient did have urine present in the catheter, however a bladder scan was done and there was "600 ml" noted within the bladder. Per the user facility the product placement was "positioned correctly". The patient did complain of "abdominal pain" and received "an analgesic". The device was removed and replaced with that of another brand. There were no photographs submitted depicting the reported complaint issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007966929-2020-00007
MDR Report Key9740138
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-21
Date of Event2020-02-11
Date Mfgr Received2020-03-04
Date Added to Maude2020-02-21
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 NameTBD
Product CodeFFG
Date Received2020-02-21
Model Number158101010190
Lot Number325388
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL ZAVODSKAYA STREET 50
Manufacturer AddressFE UNOMEDICAL LTD MINSK REGION MINSKAYA VOBLASTS


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-21

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