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

Model Number 25045051

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Mfg date: 05/2015.Based on the available information, this event is deemed a reportable malfunction.The device was not used on a patient.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that the hanger was missing from urine meter device seen while the device was still in the packaging.The device was not used on a patient.

Manufacturer Narrative

Additional information: a quality investigation was performed.An unused sample in an opened package was received for evaluation.During visual inspection of received sample, it was found that the round hook was absent and did not meet product specifications.A batch record review was conducted and no discrepancies were noted.As a result, a nonconformance has been opened to address this issue.This nonconformance will remain open until the completion of the investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

This supplemental report is being submitted due to a quality re-assessment of the reported event concluded that the hook is placed into the same package with unometer, but it is placed separately.The instructions for use states that if the customer is required to attach the hook, it is attached to unometer or if the customer doesn't want to use the hook, they can use the straps.Therefore, based on the initial reported complaint, and further review by quality, a retraction is being submitted as there was no malfunction of the device as it was unused by the customer and this is considered a non-reportable event.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: UNOMETER 500 - URINEMETER
• 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 voblast 22275 0; BO 222750
• Manufacturer (Section G): CONVATEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5174082
• MDR Text Key: 29196941
• Report Number: 3007966929-2015-00091
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: 25045051
• Device Lot Number: 197405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• 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: Initial
• Patient Sequence Number: 1