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

Model Number	AJ50641400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: DOUBLE LOOP URETERAL STENT
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1-3; humlebaek, 3050 ; DA 3050
• MDR Report Key: 10091757
• Report Number: 9610711-2020-00016
• Device Sequence Number: 14299547
• Product Code: FAD
• UDI-Device Identifier: 05708932059572
• UDI-Public: 05708932059572
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K013921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: AJ50641400
• Device Catalogue Number: AJ5064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other