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

Model Number AA64141002

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

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Visual examination of the returned product revealed the balloon with "a remanence".The balloon was inflated with 15ml of air and was then 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, creating a "pleated blistering" which increased the diameter and added "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: 12705241
• MDR Text Key: 278599388
• Report Number: 9610711-2021-00104
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040129869
• UDI-Public: 03600040129869
• 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: 10/27/2021

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: AA64141002
• Device Catalogue Number: AA6414
• 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: 10/27/2021
• 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