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

Model Number	2134601400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9672878
• Report Number: 3003814961-2020-00001
• Device Sequence Number: 2883901
• Product Code: FAQ
• UDI-Device Identifier: 00762123030196
• UDI-Public: 00762123030196
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 2134601400
• Device Catalogue Number: 2134601400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR