MAUDE Adverse Event Report: UNOMEDICAL ZAVODSKAYA STREET 50 TBD

Model Number 158101010190

Device Problem No Flow (2991)

Patient Problems Pain (1994); Urinary Retention (2119); Abdominal Distention (2601)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

Mdr3007966929-2020-00007 / device 1 of 1.Brand name: urine meter.Common device name: urine flow or volume measuring system.(b)(6).Date of manufacture: 02/2019.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that the product caused a "bladder globe due to failed urine outflow.Due to this patient referred abdominal pain." upon clarification a bladder globe is "an abnormal distension of the bladder due to the increase in the volume of urine contained therein secondary to acute urinary retention.The bladder globe is associated with suprapubic pain and reduced bladder contractility".It was reported by the user facility that the patient did have urine present in the catheter, however a bladder scan was done and there was "600 ml" noted within the bladder.Per the user facility the product placement was "positioned correctly".The patient did complain of "abdominal pain" and received "an analgesic".The device was removed and replaced with that of another brand.There were no photographs submitted depicting the reported complaint issue.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

A batch record review was performed.No non- conformance record (ncr) related to complaint issue were initiated for complaint order during production.A non-conformance for ¿stop flow from patient to chamber¿ was initiated.On a basis of the available information and investigation conducted the root cause for the issue ¿stop flow at different areas from patient to chamber was observed by health care professional (hcp) during product use¿ cannot be determined.There is a list of possible causes that were determined, but an exact root cause could not be identified.No systematic failures in manufacturing process were revealed.No samples and pictures were received.No additional investigation is needed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: (b)(4), manufacturing site: (b)(4).

• Brand Name: TBD
• Manufacturer (Section D): UNOMEDICAL ZAVODSKAYA STREET 50; fe unomedical ltd; minsk region; minskaya voblasts
• MDR Report Key: 9740138
• MDR Text Key: 183770586
• Report Number: 3007966929-2020-00007
• 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: company representative,foreig
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: 158101010190
• Device Lot Number: 325388
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1