MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number G49953

Device Problems Device Damaged Prior to Use (2284); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

The complainant reported that a 1cm (centimeter) slit was found at the end of the universa soft ureteral stent after opening.It was further noted that the distal end of the stent was torn from the first sideport through the tip.This product problem occurred prior to patient contact and there was no impact to the patient.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7427067
• MDR Text Key: 105765866
• Report Number: 1820334-2018-01104
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002499539
• UDI-Public: (01)00827002499539(17)171120(10)5460839
• Combination Product (y/n): N
• Reporter Country Code: SG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G49953
• Device Catalogue Number: USH-700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1