MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH COMPACT SET MALE URINARY INTERMITTENT DRAINAGE CATHETER WITH INTEGRAT; SINGLE-ADMINISTRATION URETHRAL CATHETERIZATION KIT, SELF-APPLIED, SINGLE-USE

Catalog Number	28422
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Urethral Stenosis/Stricture (4501)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, the complaint concerns an experienced end-user who have been performing self-catheterization for 20 years.The end-user had inserted the sc compact set catheter to empty the bladder when part of the device was detached and left inside the urethra.The end-user experienced pain and bleeding and was admitted to the er where the catheter part was surgically removed.The end-user spends the day in the er before being discharged.The following night, the end-user again experiences part of the catheter was left in the bladder when catheterizing.This time, the end-user managed to extract the catheter part himself.The two incidences occurred from the same batch according to the end user.There is no further information available.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.

• Brand Name: SPEEDICATH COMPACT SET MALE URINARY INTERMITTENT DRAINAGE CATHETER WITH INTEGRAT
• Common Device Name: SINGLE-ADMINISTRATION URETHRAL CATHETERIZATION KIT, SELF-APPLIED, SINGLE-USE
• 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: 21112585
• Report Number: 3006606901-2025-00003
• Device Sequence Number: 12941354
• Product Code: GBM
• UDI-Device Identifier: 05708932967150
• UDI-Public: 05708932967150
• Combination Product (Y/N): N
• PMA/510(K) Number: K121458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2025

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: 28422
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown