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

Model Number AA61201002

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2020

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, before insertion, an inflation test was done with no problem.A few hours after indwelling, the catheter fell off.A balloon burst was found.

Manufacturer Narrative

H3: the returned device was inflated with air and water without any abnormality.The balloon inflated without problem.

• Brand Name: FOLYSIL CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11117768
• MDR Text Key: 225123669
• Report Number: 9610711-2021-00002
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127735
• UDI-Public: 03600040127735
• 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
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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: No Information
• Device Model Number: AA61201002
• Device Catalogue Number: AA6120
• Device Lot Number: 7362400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1