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

Catalog Number	AA6114
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994)
Date of Event	11/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information several penis sores have been observed on patients.Appearance approximately 15 days after placement of the catheter.It is extremely painful for the patients.The catheter is too rigid and problems arise when the catheter remains in place for a long time.
Additional Manufacturer Narrative
Without a sample we cannot do more than a documentary investigation concerning intermediate product and tube component which revealed no anomaly during production.Storage product was checked; however, no medical device was available for finished product lot number 9226670 or with intermediate lot number 8457525.After receiving this complaint, we searched for other complaints and found four similar complaints.Checking the quality database revealed no anomaly in relation with the described defect.A risk management framework evaluation was performed and concluded 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 clinical assessment was done and concluded: in the absence of detailed information on the circumstances of use and without the incriminated device, we cannot conclude a root cause for the incident.Overall, we consider that the incident described as catheter too stiff, leading to mucosal erosion (penis sore) and intense pain, is likely related to the device.

• 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-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18287206
• Report Number: 9610711-2023-00262
• Device Sequence Number: 20500110
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 3600040127360
• Combination Product (Y/N): N
• PMA/510(K) Number: K013174
• 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): 05/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AA6114
• Device Lot Number: 9226670_AA61141002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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: Other
• Patient Sex: Unknown