MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW STR 3WAY 50ML SI CH18; SILICONE FOLEY CATHETER

Model Number AB60181002

Device Problems Fluid/Blood Leak (1250); Torn Material (3024)

Patient Problems Abdominal Pain (1685); Discharge (2225)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

According to the complaint received, patient had a catheter inserted; however, it did not stay in place or perform well for a week after placement due to the balloon being torn.Leakage, abdominal pain, and profuse discharge of urine with placement of new catheter.No part of balloon lost.

Manufacturer Narrative

The product was not available to be returned.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurence.Should the device or additional information be received, a follow up report will be filed.

• Brand Name: X-FLOW STR 3WAY 50ML SI CH18
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat-la-canéda, 2420 6; FR 24206
• Manufacturer Contact: megan daniel ; 1601 w river rd n; minneapolis, MN 55411 ; 6123024930
• MDR Report Key: 4621735
• MDR Text Key: 5577269
• Report Number: 9610711-2015-00006
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K013172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: AB60181002
• Device Catalogue Number: AB60181002
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention