MAUDE Adverse Event Report:; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number 509047

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Unometersafeti=110cm 1.5l rh (1/10pk)int.(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

It was reported 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.A non-conformance is associated with this complaint, which is closed.The investigation concludes the likely root cause for the issue ¿stop flow between patient and chamber of unometer product¿ cannot be identified on the base of information received.No corrective action is required.No additional investigation is needed.This issue will be monitored through the post market product monitoring review process.No additional information has been provided to date.Should additional information become available, a follow up report will be submitted.

• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• MDR Report Key: 6325906
• MDR Text Key: 67338833
• Report Number: 3007966929-2017-00009
• 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: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: 509047
• Device Lot Number: 225306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1