MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER DAFETI PLUS - WITH LUER-LOCK; URINOMETER, MECHANICAL

Model Number 158101310190

Device Problem Leak/Splash (1354)

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

Event Date 12/01/2014

Event Type  malfunction  

Event Description

It was reported that there was "leakage between the chamber and the bag.".

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.Add'l info requested but, no add'l pt/event details have been provided to date.Should add'l info become available a follow up report will be submitted.(b)(4).

• Brand Name: UNOMETER DAFETI PLUS - WITH LUER-LOCK
• Type of Device: URINOMETER, MECHANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol; dzerzhinsk district minsk region 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, interim associ ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4425997
• MDR Text Key: 5375146
• Report Number: 3007966929-2015-00015
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: 158101310190
• Device Lot Number: 161114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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