URINE METER 158101310190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for URINE METER 158101310190 manufactured by .

Event Text Entries

[83749362] (b)(6). (b)(4). Inserted the following statement for clarification- the following complaint originated from (b)(6) hospital but was reported via the distributor: (b)(4). Based on the available information, this event is deemed to be a reportable malfunction. Additional patient/event details have been requested but none have been 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


[83749363] The distributor received reports from two hospitals stating? It is difficult to drain the urine from the tubing to the chamber.? It was reported that the urine did not flow freely in the tubing when the unometer safety was connected to the catheter; however, when the unometer was not connected to the catheter, urine flowed freely. The reporter(s) were unable to provide any additional patient(s) or event(s) details as they stated this information is confidential. Therefore, it is unknown how many patient(s) were involved per the quantity of device(s) reported by each hospital. It was further reported that a patient required a urine test (results were not provided) and the unometer safeti plus was replaced with another unometer. The reporter was unable to provide specifics as to which hospital the following information pertains to. There was no patient(s) harms reported. No further information was able to be obtained or provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007966929-2017-00043
MDR Report Key6817003
Date Received2017-08-24
Date of Event2017-08-01
Date Mfgr Received2017-10-26
Date Added to Maude2017-08-24
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 Report0

Device Details

Brand NameURINE METER
Generic NameDEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
Product CodeFFG
Date Received2017-08-24
Model Number158101310190
Lot Number302598
OperatorNURSE
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-24

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