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

Catalog Number ACA107

Device Problem Unsealed Device Packaging (1444)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

According to the available information, prior to use, there is no weld seam on the packaging causing the device to not be sterile.

• 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 (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: 18941199
• MDR Text Key: 338323479
• Report Number: 9610711-2024-00067
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 03600040160343
• UDI-Public: 3600040160343
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ACA107
• Device Lot Number: 9498389_ACA1071002
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 12/11/2023
• 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