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

Catalog Number	28692 / 286920
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Hematuria (2558)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, a male end-user used the speedicath compact male catheter.The end-user said the catheterisation felt weird, but that the urine drained normally.When the end-user withdrew the catheter there was bleeding afterwards.The bleeding was described to continue for 24 hours, with the exception of the night-time.After the 24 hours the end-user contacted coloplast.The end-user was advised to contact a health care professional (hcp), which he did, and was told to monitor the bleeding for the weekend.After 4 hours, the end-user felt bad, and after an additional hour he developed a fever (38.5°c) and felt sick.He contacted the hcp again and was told to go the emergency room.The end-user went to the emergency room by ambulance and spent the weekend there.Several tests were performed, in which one showed escherichia coli (e.Coli) in the urine, for which the end-user was prescribed treatment with antibiotics for 10 days.No further information is available at this time.

• Brand Name: SPEEDICATH COMPACT MALE URINARY INTERMITTENT DRAINAGE CATHETER
• Common Device Name: SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usgab giovanna abugre ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18160121
• Report Number: 3006606901-2023-00017
• Device Sequence Number: 12423641
• Product Code: GBM
• UDI-Device Identifier: 05708932579032
• UDI-Public: 05708932579032
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K143182
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2023

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: 03/26/2025
• Device Catalogue Number: 28692 / 286920
• Device Lot Number: 9098259_2869201032
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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: Male