MAUDE Adverse Event Report: TBD

Model Number 509047

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Brand name: unometer safeti.Common device name: device urine flow rate measuring, non-electrical).Pro-code: ffg).(b)(6).Based on the available information, this event is deemed a product malfunction.No patient harm was reported.Additional details have been requested but not provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

Complaint reported by a doctor that "the urine did not flow into the collection room" of the device.The device was removed.No further information was available.

Manufacturer Narrative

A batch record review was performed; and a non-conformance (nc) from a previous complaint was opened which is associated with this reported issue.The nc has been closed and no further investigation is required.The investigation concluded that the likely root cause for the issue, "stop flow between patient and chamber of the unometer product" cannot be identified based on the information received.This issue will be monitored through the post market product monitoring review process.No additional patient/details has been provided regarding the reported event.Should additional information become available at a later date, a follow-up report will be submitted.

• Brand Name: TBD
• MDR Report Key: 6329946
• MDR Text Key: 67589892
• Report Number: 3007966929-2017-00005
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: 509047
• Device Lot Number: 227856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1