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 the burette contents drained very slowly - almost at a "trickle" pace.

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; therefor,e 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; dzerzhinsk district minsk region 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak associate ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4340312
• MDR Text Key: 5199542
• Report Number: 3007966929-2014-00129
• 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