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

Catalog Number AA6114

Device Problems Material Too Rigid or Stiff (1544); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Pressure Sores (2326)

Event Date 11/10/2023

Event Type  Injury  

Event Description

According to the available information, extremely painful penile sores have been observed on patients with indwelling catheters.The sores appeared approximately 15 days after placement.It was reported the catheter is too rigid and problems arise when the catheter remains in place for a long time.

Manufacturer Narrative

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 information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.

Manufacturer Narrative

H1: corrected to serious injury.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
• Type of Device: 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: 18288171
• MDR Text Key: 330156122
• Report Number: 9610711-2023-00266
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: AA6114
• Device Lot Number: 9226670_AA61141002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Date Device Manufactured: 06/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other