MAUDE Adverse Event Report: COLOPLAST A/S FREEDOM CATH; FREEDOM SELF-CATH NELATON CH14

Model Number	5045301400
Health Effect - Clinical Codes	Perforation of Vessels (2135); Hematuria (2558)
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 end user (eu) who has been catheterizing for years.Over the last 5 or so months his prostate has enlarged and he has noticed bleeding during catheterization.This bleeding started out as maybe a 1/2 inch smear of blood on his catheter to now quite a bit more.Eventually the blood was observed in his bladder for which he underwent an ablation surgical procedure to help ease the catheterization process.The eu was discharged on (b)(6) 2021 and currently has a foley catheter in.His doctor has recommended the use of softer catheters with a coude tip for future catheterization.No additional information was provided.

• Brand Name: FREEDOM CATH
• Common Device Name: FREEDOM SELF-CATH NELATON CH14
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12009635
• Report Number: 3005945907-2021-00004
• Device Sequence Number: 14370953
• Product Code: EZD
• UDI-Device Identifier: 05708932576307
• UDI-Public: 05708932576307
• Combination Product (Y/N): N
• PMA/510(K) Number: K100878
• 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): 06/16/2021

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: 5045301400
• Device Catalogue Number: 50453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 06/16/2021
• 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; Required Intervention