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

Catalog Number	28492 / 284920 / 284929
Medical Device Problem Code	Inadequate or Insufficient Training (1643)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Syncope/Fainting (4411)
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint concerns a male end user who has used a speedicath standard ch12 tiemann catheter.The end user had been using ch12 tiemann catheters for a few weeks without complications, however one day, due to not being clear on which direction to insert the catheter, had experienced a lot of bleeding.The end user mentions that it took approximately a day for the bleeding to stop.The end user had undergone a cystoscopy to investigate if any further underlying complications might have been associated with the issue.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 STANDARD URINARY INTERMITTENT DRAINAGE CATHETER
• Common Device Name: SINGLE-ADMINISTRATION URETHRAL DRAINAGE CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam; humlebæk 3050 ; DA 3050
• Manufacturer Contact: usgab giovanna hayford-quansah ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 23300015
• Report Number: 3015131144-2025-00001
• Device Sequence Number: 20049635
• Product Code: GBM
• UDI-Device Identifier: 05708932020398
• UDI-Public: 05708932020398
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

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: 28492 / 284920 / 284929
• Device Lot Number: 10304874_2849201006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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: Life Threatening
• Patient Sex: Unknown