MAUDE Adverse Event Report: UNOMEDICAL LTD UNOMETER SAFETI+,150CM,2L,RH; DEVICE, URINE FLOW RATE MEASURING

Device Problem Restricted Flow rate (1248)

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

Event Type  malfunction  

Manufacturer Narrative

Exp date: 07/2020; manuf.Date: 08/2015.Based on the available information, this event is deemed a reportable malfunction.Additional patient/event information was requested but was not received, should additional information become available, a follow-up report will be submitted.There is one (1) other device associated with this product complaint.A separate fda form 3500a has been generated to address each device.(b)(4).

Event Description

A nurse reported that "the urine does not flow into the bag.Probably the problem is settled in a non-return valve in a bag." the initial reporter was unable to provide the specific number of devices or patients impacted due to the reported malfunction of the device.

Manufacturer Narrative

This supplemental report is being submitted after a detailed batch review was performed.There were no discrepancies related to complaint issue found.Additionally after reviewing a photo received, it was noted that the picture showed the stop flow during closed position of open/close tap.In the closed position urine does not flow to the bag.When open/close tap is in opened position, urine should flow to the bag.A previous investigation is applicable to this complaint and the investigation has been closed.Therefore, this complaint will be closed without further action.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: UNOMETER SAFETI+,150CM,2L,RH
• Type of Device: DEVICE, URINE FLOW RATE MEASURING
• Manufacturer (Section D): UNOMEDICAL LTD; zavodskaya street, 50; fanipol dzerzhinsk district; minsk region, minskaya voblasts 22275 0; BO 222750
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5473438
• MDR Text Key: 39442544
• Report Number: 3007966929-2016-00009
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2016
• 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: Initial
• Patient Sequence Number: 1