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

Catalog Number	AA6110
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/12/2025
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.
Event or Problem Description
According to the available information difficulty removing the mandrel, it seemed stuck to the probe.The nurse had to force it out, which caused pain and discomfort.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we find one other complaint regarding 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.We can conclude that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.A similar case study was performed on folysil silicone pediatric, on the same defect "mandrel was difficult to remove" from november 2021 to november 2025, 2 similar case were found.
Event or Problem Description
According to the available information difficulty removing the mandrel, it seemed stuck to the probe.The nurse had to force it out, which caused pain and discomfort.

• 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: 23863226
• Report Number: 9610711-2025-00511
• Device Sequence Number: 21155878
• 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): 03/27/2026

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: 12/22/2025
• Supplement Report FDA Received Date: 03/30/2026
• 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