MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number	AA6110
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.B3: estimated date.
Event or Problem Description
According to the available information while inserting a urinary catheter into a child for a cystography, difficulty was encountered in passing the bladder sphincter, as the child was particularly under tension.The catheter balloon, which had been tested prior to insertion and found to be intact, was inflated without any apparent difficulty.When the mandrel was removed, unusual resistance was observed, associated with torsion of the catheter tip.The catheter was removed by exercising above-normal force.During the radiological examination, the radiologist noted that the catheter was not in place and that the balloon was inflated at the level of the urethra.The catheter was then removed in the radiology department.The incident led to the postponement of the patient's examination.
Additional Manufacturer Narrative
According to the complaint description, the lot number is available but not the sample.After receiving this complaint, we searched for other complaint and we found one other complaint on the same defect "difficulty to remove the mandrel" on the lot number.Unfortunately without sample from our customer we cannot do more than documentary investigation which didn¿t reveal any anomaly recorded during production checking quality database revealed no anomaly in connection with the described defect.
Event or Problem Description
According to the available information while inserting a urinary catheter into a child for a cystography, difficulty was encountered in passing the bladder sphincter, as the child was particularly under tension.The catheter balloon, which had been tested prior to insertion and found to be intact, was inflated without any apparent difficulty.When the mandrel was removed, unusual resistance was observed, associated with torsion of the catheter tip.The catheter was removed by exercising above-normal force.During the radiological examination, the radiologist noted that the catheter was not in place and that the balloon was inflated at the level of the urethra.The catheter was then removed in the radiology department.The incident led to the postponement of the patient's examination.

• Brand Name: FOLYSIL SILICONE CATHETER
• Common Device Name: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat la canéda cedex 24200 ; FR 24200
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 23658326
• Report Number: 9610711-2025-00496
• Device Sequence Number: 10055088
• Product Code: EZL
• UDI-Device Identifier: 03600040127100
• UDI-Public: 3600040127100
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K233411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AA6110
• Device Lot Number: 8911144_AA61101002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2022
• 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
• Patient Sex: Unknown