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

Catalog Number	28496 / 284969
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, the end user received a couple samples of speedicath and after using them, he was bleeding and had to be admitted to the hospital.No further information is available at this time.

• 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: 22519522
• Report Number: 3006606901-2025-00008
• Device Sequence Number: 15660193
• Product Code: GBM
• UDI-Device Identifier: 05708932020411
• UDI-Public: 05708932020411
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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 Catalogue Number: 28496 / 284969
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Male