URINE METER 25001183

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-07-25 for URINE METER 25001183 manufactured by .

Event Text Entries

[81070313] (b)(6). Based on the available information, this event is deemed a product malfunction. No serious injury was reported. Additional details have been requested but not provided to date. Should additional information become available, a follow up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[81070314] Complaint received from a hospital in (b)(6) reporting that "the problem is that when they connected the catheter to the unometer, the urine does not flow. " clarification was obtained: reporter stated that the patient experienced urinary retention and "the nurses realized that the correct urine descent was not being produced since they started using the device. When they observed this incidence, they made disconnections of it from the bladder catheter or they pricked it to favor the air entrance in the system and favor the urine descent. " reporter stated that before the device was attached to the indwelling catheter, "the urine flowed without any problem. [however], at the time of the placement of the device, the professionals observed a significant decrease in the urine descent. " the reporter verified that the indwelling catheter was flushed, was patent and returned no clots or sediment, but urine did not flow. Staff replaced unit in accordance with hospital protocol.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007966929-2017-00038
MDR Report Key6742199
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2017-07-25
Date Mfgr Received2017-09-11
Date Added to Maude2017-07-25
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameURINE METER
Generic NameDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
Product CodeFFG
Date Received2017-07-25
Model Number25001183
Lot Number307324
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-25

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