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

Catalog Number AA6120

Device Problem Unintended Deflation (4061)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2023

Event Type  malfunction  

Event Description

According to the available information the balloon was found deflated.A new catheter was inserted successfully.No adverse patient events were reported.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19157304
• MDR Text Key: 341005417
• Report Number: 9610711-2024-00093
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127735
• UDI-Public: 3600040127735
• 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
• Type of Report: Initial
• Report Date: 04/22/2024

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: AA6120
• Device Lot Number: 9226766_AA61201002
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2024
• Date Device Manufactured: 06/22/2023
• 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