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

Catalog Number ACA106

Device Problem Unsealed Device Packaging (1444)

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

Event Type  malfunction  

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 available information, this device was not able to be used due to unsealed packaging.The primary packaging envelope was open and not properly sealed.The device was no longer sterile and could not be used.

• 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: 17936620
• MDR Text Key: 325703717
• Report Number: 9610711-2023-00221
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 03600040160275
• UDI-Public: 3600040160275
• 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: 10/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ACA106
• Device Lot Number: 9191002_ACA1061002
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 05/26/2023
• 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