MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER¿ 500 - URINEMETERS; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number 25104742

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

Expiration date (01/2020).Manufacturing date (02/2016).Based on the available information, this event is deemed a reportable malfunction.No patient harm was reported.Additional information has been requested but not received to date.When additional information becomes available, a follow-up report will be submitted.Reported to the fda on september 09, 2016.(b)(4).Note: there is another case associated with this complaint.A separate fda form 3500a has been generated to address the other case.

Event Description

It was reported that,"the intensive therapy unit (itu) have raised an issue that the bag is falling off too easily from its connection on the urine meter and is leaking at that point." photo attached for review.During follow-up it was reported that the device became detached where the bag attaches to the base of the chamber at its draining point, which caused the leakage noted.No further information was available.

Manufacturer Narrative

This supplemental is being retracted based on further review by quality of the reported complaint.An initial mdr was submitted on september 09, 2016 in error for the malfunction noted.This is considered a non-reportable event.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on october 11, 2016.(b)(4).

• Brand Name: UNOMETER¿ 500 - URINEMETERS
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street; 50 fanipol dzerzhinsk district; minsk region, minskaya voblast 22275 0; BO 222750
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5940785
• MDR Text Key: 54401849
• Report Number: 3007966929-2016-00076
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25104742
• Device Lot Number: 226937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1