MAUDE Adverse Event Report: COLOPLAST A/S RELEEN INLINE URINARY INDWELLING DRAINAGE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number 28764

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

According to the available information, the balloon burst.The patient presented to the emergency department with urinary retention.The patient was re-catheterized.It was noted that the balloons had been filled with 10ml, but should have been filled with 5ml.

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 information 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.

• Brand Name: RELEEN INLINE URINARY INDWELLING DRAINAGE CATHETER
• Type of Device: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18040178
• MDR Text Key: 326979296
• Report Number: 9610711-2023-00232
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 05708932906272
• UDI-Public: 5708932906272
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 28764
• Is the Reporter a Health Professional?: 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