MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER

Model Number 2876811800

Device Problem Device Fell (4014)

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

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: releen inline ch18 male.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information the patient had a releen catheter inserted and returned the next day with the catheter and said that it had fallen out that morning.He said that he heard it go ¿pop¿ in the middle of the night.Upon inspection the balloon appears to have split in a straight line, so i don¿t think there is any debris that could have been left behind.

• Brand Name: FOLYSIL CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15152709
• MDR Text Key: 304627206
• Report Number: 9610711-2022-00052
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2022

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 Model Number: 2876811800
• Device Catalogue Number: 287681
• Device Lot Number: 7909694
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 08/02/2022
• Date Device Manufactured: 05/07/2021
• 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