MAUDE Adverse Event Report: COLOPLAST A/S FREEDOM CATH; FREEDOM SELF-CATH NELATON CH16

Model Number	5045401400
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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
This case involves a male patient who stated that he recently had a severe urinary tract infection (uti) that required him to go to the hospital.The end-user had experienced utis before and was familiar with using intermittent catheters.The end-user did seek medical attention for the uti, but it is unclear whether it was his own doctor, emergency room or admission to the hospital.No information about treatment or medication could be obtained.The end-user has fully recovered with no lasting damage or issues.The end-user states that there was nothing wrong with the catheters.No additional information was provided.

• Brand Name: FREEDOM CATH
• Common Device Name: FREEDOM SELF-CATH NELATON CH16
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11426654
• Report Number: 3005945907-2021-00002
• Device Sequence Number: 14396913
• Product Code: NNX
• UDI-Device Identifier: 05708932999458
• UDI-Public: 05708932999458
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2021

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: 5045401400
• Device Catalogue Number: 50454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/07/2021
• 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: Hospitalization