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

Catalog Number AA6106

Device Problem Obstruction of Flow (2423)

Patient Problem Urinary Retention (2119)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

According to the available information bladder globes on repeating catheters.

Event Description

According to the available information bladder globes on repeating catheters.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9261039 with the same defect.This product was made by our subcontractor which was informed about this issue.In february we received subcontractor's investigation which revealed no anomaly recorded during production.The potential root cause could be a raw material's balloon.A similar case study was performed based on same item number (b)(4), same defect: drainage issue over last four years: one similar case was found.Without the sample we cannot do more than the documentary investigation which revealed no anomaly in relation to the describe defect on this complaint.

• 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: 18435453
• MDR Text Key: 331985163
• Report Number: 9610711-2024-00001
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 3600040126844
• 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: 05/22/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: AA6106
• Device Lot Number: 9261039_AA61061002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2023
• 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