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

Catalog Number	AA6118
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Ulcer (2274); Pressure Sore/Ulcer (2326)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot comment on the condition of the device.Should additional information 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.B3: estimated date.
Event or Problem Description
According to the available information, patient had been catheterized for more than a week and experienced urinary meatus eschar and an ulcer.
Event or Problem Description
According to the available information, patient had been catheterized for more than a week and experienced urinary meatus eschar and an ulcer.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found three other complaints regarding the lot number 9737189 ((b)(4) = balloon burst and (b)(4) = traumatic catheter).According to the information known quality database was checked and revealed no anomaly recorded to this defect.A similar case study was performed based on folysil reference product, from december 2020 to december 2024, 10 similar cases were found.The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art level.Based on this, 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.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 20892690
• Report Number: 9610711-2024-00343
• Device Sequence Number: 18402864
• Product Code: EZL
• UDI-Device Identifier: 03600040127605
• UDI-Public: 3600040127605
• 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): 02/20/2025

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: Health Professional
• Device Catalogue Number: AA6118
• Device Lot Number: 9737189_AA61181002
• 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: 12/10/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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: Other
• Patient Sex: Unknown