MAUDE Adverse Event Report: COLOPLAST A/S SINGLE LOOP URETERAL STENT; POLYMERIC URETERAL STENT

Catalog Number AC4407

Device Problem Unsealed Device Packaging (1444)

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

Event Type  malfunction  

Event Description

According to the available information prior to use, the sterile bag was not sealed.It was open.

Manufacturer Narrative

No other complaints were found for the lot number.

• Brand Name: SINGLE LOOP URETERAL STENT
• Type of Device: POLYMERIC URETERAL STENT
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19202505
• MDR Text Key: 341276945
• Report Number: 9610711-2024-00099
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 03600040150740
• UDI-Public: 3600040150740
• Combination Product (y/n): N
• PMA/PMN Number: K201436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AC4407
• Device Lot Number: 9351925_AC44071002
• Date Device Manufactured: 09/19/2023
• 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