MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; FOLEY CATHETER

Model Number AA61161002

Device Problems Burst Container or Vessel (1074); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the balloon bursts and the catheter does not stay in place.

• Brand Name: FOLYSIL CATHETER
• Type of Device: FOLEY CATHETER
• 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: ussoga sarah o'gara ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10468508
• MDR Text Key: 204917205
• Report Number: 9610711-2020-00051
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127490
• UDI-Public: 03600040127490
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AA61161002
• Device Catalogue Number: AA6116
• Device Lot Number: 7193432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2020
• Date Device Manufactured: 12/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1