MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER¿ 500 - URINEMETERS; DEVICE, URINE FLOW RATE MEASURING

Model Number 158100410190

Device Problem Positioning Problem (3009)

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

Event Type  malfunction  

Manufacturer Narrative

Expiration date (03/2020).Manufacturing date (04/2016).Based on the available information, this event is deemed a reportable malfunction.No patient harm was reported.A batch record indicates that no non-conformances and deviations related to complaint issue were initiated.The batch record review resulted in a discrepancy which was investigated in a previous complaint, and remains open.Sterilization was performed in accordance with parameters.The batch was released according to requirements.A sample has been received for this complaint, which was evaluated.It was noted that the cylinder was glued with the chamber.Therefore, this complaint will remain open until the investigation is complete.This issue will be monitored through the post market product monitoring review process.Additional information has been requested but not received to date.When additional information becomes available, a follow-up report will be submitted.Reported to the fda on september 08, 2016.(b)(4).

Event Description

Complaint received reporting that the "valve is not rotatable." it is unknown if the product was used on a patient.No further information was available.

Manufacturer Narrative

The investigation associated with the non-conformance has been approved and is complete from a previous complaint issue reported.On the basis of information received the investigation concludes that the true root cause for the issue "the cylinder is glued to the measurement chamber" cannot be identified.The likely root cause is operator mistake during gluing process.Probability of this issue was calculated for the period from (b)(6) 2013 through the 2nd quarter of 2016 corresponds to the remote occurrence rates, so the trend of such complaints will be monitored.No corrective action is required and this complaint will be closed.This issue will be monitored through the post market product 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 (b)(6) 2016.

• 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, minskaya voblasts 22275 0; BO 222750
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5937909
• MDR Text Key: 54278078
• Report Number: 3007966929-2016-00075
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: BO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158100410190
• Device Lot Number: 232753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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