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

Model Number 25104742

Device Problems Delivered as Unsterile Product (1421); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 02/2020; manufacture date: 03/2016.Based on the available information, this event is deemed a reportable malfunction.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that a hair was found in the packaging of the device, the device was not used.No further patient/event information was provided.

Manufacturer Narrative

A batch record indicates that no non-conformances (nc) and deviations related to complaint issue were initiated.A batch record review resulted in a discrepancy which was investigated in a previous related complaint, which has been closed.The previous investigation defines the root causes for the issue of foreign particles inside package and that investigation remains in progress.Sterilization was performed in accordance with parameters.The batch was released according to requirements.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 september 15, 2016.

• Brand Name: UNOMETER¿ 500 - URINEMETERS
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• 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: 5877316
• MDR Text Key: 52167167
• Report Number: 3007966929-2016-00066
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/03/2016

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: 25104742
• Device Lot Number: 228811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2016
• 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?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1