MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number AA64161002

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Visual examination of the returned product found a balloon "with a remanence." the balloon was inflated with 15ml of air and was deflated; the balloon was deformed due to over-inflation by the user.

Event Description

According to the available information, the balloon did not completely deflate during withdrawal.It created a "pleated blistering" which increased the diameter and "add reliefs" making the withdrawal difficult and painful for the patient.

• Brand Name: FOLYSIL CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12661040
• MDR Text Key: 277397490
• Report Number: 9610711-2021-00089
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040129975
• UDI-Public: 03600040129975
• 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
• Report Date: 10/19/2021

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 Model Number: AA64161002
• Device Catalogue Number: AA6416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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