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

Catalog Number	28414
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Urethral Stenosis/Stricture (4501)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, a male end-user was hospitalized due to an incident with a speedicath standard male urinary catheter.The incident was described to be a punctured prostate, which caused a blood vessel to burst.The end-user experienced bleeding, and dizziness and was treated under anaesthesia to clear up blood and debris.He was hospitalized for 3 days and were discharged with an indwelling catheter for 10-14 days as well as antibiotics, vitamins and iron pills.The end-user is an experience catheter user and have used intermittent catheters for 4 years and has not changed his insertion routine.He has benign prostatic hyperplasia (bph) but stated that when inserting the catheter before the incident he did not feel any resistance at all.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; humlebæk 3500 ; DA 3500
• Manufacturer Contact: usgab giovanna abugre ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19361090
• Report Number: 3006606901-2024-00011
• Device Sequence Number: 11704744
• Product Code: GBM
• UDI-Device Identifier: 05708932020275
• UDI-Public: 05708932020275
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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: 05/16/2024
• Device Catalogue Number: 28414
• Device Lot Number: 8572171_2841401400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2022
• 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; Other
• Patient Sex: Unknown