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 / 284221 / 284229
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, this incident concerns an experienced end-user who have been self-catheterising for years.When the incident happened, the end-user inserted and drained the bladder as normally.When withdrawing the catheter, there was blood on the catheter, and the tip-part was missing (the part the telescopes out).The end-user went to the er, where surgery was needed to remove the part.The end-user was hospitalized for three days, there were no additional complications, and he has been informed that the doctor expects him to fully recover.He is self-catheterizing again, after being equipped with a foley catheter during the hospital stay.The end-user has no underlying conditions as strictures or enlarged prostate.The end-user is trained in using the catheter and he did follow the instructions for use (ifu).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 holtedam; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): NYÍRBÁTOR
• Manufacturer Contact: usgab giovanna hayford-quansah ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 23989467
• Report Number: 3006606901-2026-00001
• Device Sequence Number: 10536221
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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: 07/05/2025
• Device Catalogue Number: 28422 / 284221 / 284229
• Device Lot Number: 9273739_2842211400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2023
• 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; Life Threatening
• Patient Sex: Unknown