MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD URINARY INTERMITTENT DRAINAGE CATHETER; SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER

Catalog Number	28416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Sepsis (2067)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, this complaint concerns an end user (eu) who has been using sc standard male catheter for a few months.The eu has received training in self-catheterisation by the doctor and catheterises according to the instructions for use (ifu).The eu has experienced some trouble passing the catheter around the prostate as well as pain/discomfort when inserting.A few weeks ago, the eu experienced bleeding and reached out to the urologist.More recently (dates not specified), the eu got a blood infection and was admitted to the hospital for around a week, where the eu was treated with iv antibiotics.

• Brand Name: SPEEDICATH STANDARD URINARY INTERMITTENT DRAINAGE CATHETER
• Common Device Name: SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam holtedam; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usgab giovanna abugre ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21065069
• Report Number: 3006606901-2025-00001
• Device Sequence Number: 14307207
• Product Code: GBM
• UDI-Device Identifier: 05708932020299
• UDI-Public: 5708932020299
• Combination Product (Y/N): N
• PMA/510(K) Number: K023254
• 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): 01/03/2025

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 Expiration Date: 07/21/2026
• Device Catalogue Number: 28416
• Device Lot Number: 9885710_2841601400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown