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

Model Number 25039742

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/11/2014

Event Type  malfunction  

Event Description

It was reported that an unometer was leaking at the valve.

Manufacturer Narrative

Based on the eval info, this event is deemed a reportable malfunction.It was stated that the device was removed or discontinued.Add'l f/u event / pt info was requested on 06/12/2014, 06/16/2014 and 06/17/2014.No add'l pt/event details have been provided to date.Should add'l info become available, a f/u report will be submitted.A return sample for eval is not expected.

• Brand Name: UNOMETER 500 - URINEMETERS
• Type of Device: DEVICE, URINE FLOW RATE MEASURING
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzerihingk district; minsk region, minskaya voblasts 2227 50; BO 222750
• Manufacturer Contact: matthew wallenciak, dir. ; 211 american avenue; greensboro, NC 27409-0000 ; 9083779293
• MDR Report Key: 3997910
• MDR Text Key: 4712877
• Report Number: 3007966929-2014-00044
• 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,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: 25039742
• Device Catalogue Number: 25039742
• Device Lot Number: 489597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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