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

Model Number HA61161002

Device Problem Obstruction of Flow (2423)

Patient Problems Pain (1994); Urinary Retention (2119); Burning Sensation (2146); Unspecified Tissue Injury (4559)

Event Date 11/05/2022

Event Type  Injury  

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.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.E2015 was used to capture the reported ¿ablation¿ as context of the event reasonably suggests ¿ablation¿ was used to describe tissue injury/irritation.

Event Description

According to available information, this device required replacement due to not draining.The patient reported burning sensation in his penis and feeling that urine was not draining.The balloon was deflated and reinflated.There was a presence of yellow liquid and unsure if it was urine.Patient did not have improvement and reported lower abdominal pain.The patient had an ablation and device replacement.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16782454
• MDR Text Key: 313706651
• Report Number: 9610711-2023-00064
• Device Sequence Number: 1
• Product Code: EZL
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HA61161002
• Device Catalogue Number: HA6116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/20/2023
• 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
• Patient Outcome(s): Required Intervention