MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER 500, URINE METER (WITH FIXED BAG AND; URINOMETER, MECHANICAL

Model Number 25039742

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Event Description

It was reported the urinometer disconnected from the patient's catheter while in use.This issue occurred an unknown number of times with an unknown number of devices.No patient complications were reported as a result of this event.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.No further information was available at the time of the report.There were no reports of the patient being harmed as a result of this malfunction.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

Additional informational was received june 09, 2015.The lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow up report will be submitted.Reported to the fda on june 30, 2015.

• Brand Name: UNOMETER 500, URINE METER (WITH FIXED BAG AND
• 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 ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4837971
• MDR Text Key: 22034956
• Report Number: 3007966929-2015-00055
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

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 Model Number: 25039742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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