MAUDE Adverse Event Report: COLOPLAST A/S MOVEEN NIGHT BAG,2000/140; BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE

Model Number 2134601400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, during the night the urine flow stopped, which caused the urine to "back up into his bladder" and hereafter he got an uti, for which he was hospitalized for 8 days and received antibiotics.The patient is now home and recovering.It is unclear whether the tube of the urine bag, the mec or both were twisted and caused the blocked urine flow.The user describes that he is using the urine bag as described in the ifu, expect for washing it with bleach and water and re-using it.

• Brand Name: MOVEEN NIGHT BAG,2000/140
• Type of Device: BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S TATABANYA; b?zavir?g u. 15; tatab?nya, 2800 ; HU 2800
• Manufacturer Contact: mike bumgarner ; 1601 west river road n; minneapolis, MN 55411 ; 6122630488
• MDR Report Key: 9672878
• MDR Text Key: 177849725
• Report Number: 3003814961-2020-00001
• Device Sequence Number: 1
• Product Code: FAQ
• UDI-Device Identifier: 00762123030196
• UDI-Public: 00762123030196
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2134601400
• Device Catalogue Number: 2134601400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR