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

Model Number 5045401400

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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event 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
• Type of Device: FREEDOM SELF-CATH NELATON CH16
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST (CHINA) LTD.; no.202, bao cheng rd; xiang zhou distric; zhuhai 51903 0; CH 519030
• Manufacturer Contact: usllam linda linsday-ambroziak ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11426654
• MDR Text Key: 238307580
• Report Number: 3005945907-2021-00002
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 05708932999458
• UDI-Public: 05708932999458
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 5045401400
• Device Catalogue Number: 50454
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/07/2021
• 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
• Patient Outcome(s): Hospitalization