MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS, 150CM 1,5L,RH; URINOMETER, MECHANICAL

Model Number 158100710190

Device Problem Occlusion Within Device (1423)

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

Event Date 04/30/2015

Event Type  malfunction  

Event Description

It was reported urine did not flow out from bladder.It was further reported that the device was removed and replaced with another device fro a different lot.

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.Should additional info become available, a follow-up report will be submitted.

Manufacturer Narrative

A quality complaint investigation was performed.Samples were not received.A detailed batch record review was performed.No non-conformance reports related to the complaint issue was initiated.The root cause investigation for the issue "stop flow between pt and chamber" was performed.The true root cause cannot be identified based on the info received.No corrective action is required at the moment.A previous investigation is applicable to this complaint investigation.This previous investigation is closed.Therefore this complaint will be closed without further action.No add'l pt/event details have been provided to date.Should add'l info become available, a f/u report will be submitted.

• Brand Name: UNOMETER SAFETI PLUS, 150CM 1,5L,RH
• Type of Device: URINOMETER, MECHANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzerzhinsk district; minsk region, minskaya voblasts 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4788184
• MDR Text Key: 5853477
• Report Number: 3007966929-2015-00045
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K89673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

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: 08/01/2019
• Device Model Number: 158100710190
• Device Lot Number: 167641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 05/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• 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