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

Model Number 158101310190

Device Problem Occlusion Within Device (1423)

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

Event Date 10/28/2014

Event Type  malfunction  

Event Description

The hlth care professional stated once the burette was filled staff had difficulty draining the contents into the end drainage back.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There are a total of nine (9) cases associated with this product; therefore, nine separate 3500a forms have been generated to address the other cases.There were no reports of the pt being harmed as a result of this malfunction.No additional pt/event details have been provided to date.Should additional info become available, a follow-up report will be submitted.(b)(4).

• Brand Name: UNOMETER 500 - URINEMETERS
• Type of Device: URINE FLOW RATE MEASURING NON-ELECTR
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50 fanipol; minskaya voblasts; dzerzhinsk district minsk region 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4340289
• MDR Text Key: 5176126
• Report Number: 3007966929-2014-00130
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Model Number: 158101310190
• Device Lot Number: 162015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2014
• Initial Date FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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