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 05/19/2014

Event Type  malfunction  

Event Description

It was reported that the "bag drill leaked on the lateral weld which caused urine flow on the floor.".

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.This malfunction compromises that accuracy of the urine output measurement.The device was used on a patient, however, there was no report of harm to the patient.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.A return sample for evaluation 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; dzerzhinsk district minsk region 2227 50; BY 222750
• Manufacturer Contact: matthew walenciak, assoc dir ; 211 american ave; grensboro, NC 27409-0000 ; 9083779293
• MDR Report Key: 4002214
• MDR Text Key: 4959691
• Report Number: 3007966929-2014-00027
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Model Number: 25039742
• Device Catalogue Number: 25039742
• Device Lot Number: 65413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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