MAUDE Adverse Event Report: COLOPLAST A/S IMAJIN DOUBLE LOOP URETERAL STENT

Model Number AJ50641400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

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.

Event Description

According to the available information, the patient that had the stent placed subsequently developed a spontaneous perforation of the bladder, reportedly due to the stent.

Manufacturer Narrative

After receiving this complaint, we could not search for other complaint as the lot number is not available.Unfortunately, no sample or photo available, we have not been given sufficient information to perform an investigation.This complaint will be used for trend analysis.Root cause unknown.It is concluded that the risks identified are still acceptable and considered as safe.No similar case for aj50641400 since ce marking.

• Brand Name: IMAJIN DOUBLE LOOP URETERAL STENT
• Type of Device: DOUBLE LOOP URETERAL STENT
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1-3; humlebaek, 3050 ; DA 3050
• MDR Report Key: 10091757
• MDR Text Key: 192165198
• Report Number: 9610711-2020-00016
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 05708932059572
• UDI-Public: 05708932059572
• Combination Product (y/n): N
• PMA/PMN Number: K013921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/21/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: AJ50641400
• Device Catalogue Number: AJ5064
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other