MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER 500 - URINEMETERS

Model Number 158101210190

Device Problem Defective Device (2588)

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

Event Date 09/16/2014

Event Type  malfunction  

Event Description

It is reported by the field nurses the blue lever does not allow the turn required for the drainage of the liquid.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.It was further reported the event happened with five (5) products.It was necessary to change the urine filters on the device.There were no reports of the patient being harmed as a result of this malfunction.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.This complaint involves two (b)(4) different issues with (b)(4) devices; therefore, additional nine (b)(4) cases are associated with this product; therefore, (b)(4) separate fda form 3500 a have been generated to address the other cases.

• Brand Name: UNOMETER 500 - URINEMETERS
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzershinsk district; mknskaya voblasts 00002 2275; BO 0000222750
• Manufacturer Contact: matthew walenciak ; 211 american ave.; greensboro, NC 27409-0000 ; 9083779293
• MDR Report Key: 4188004
• MDR Text Key: 5160617
• Report Number: 3007966929-2014-00088
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: 158101210190
• Device Catalogue Number: 158101210190
• Device Lot Number: 654979
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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