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

Model Number AB63181002

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

Patient identifier: (b)(6).Date of event: (b)(6) 2014.According to the information received, a catheter was reported to have fallen out of the patient in bed.The balloon was pierced.

Manufacturer Narrative

The product has not been returned.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 the device or additional information be received, a follow up report will be filed.

• Brand Name: X FLOW DUFO 3WAY SIL 50ML CH18
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING FRANCE, SAS; usine du pontet bp 89; sarlat, ; FR
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6123024987
• MDR Report Key: 4262854
• MDR Text Key: 5108961
• Report Number: 9610711-2014-00031
• 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,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2019
• Device Model Number: AB63181002
• Device Catalogue Number: AB63181002
• Device Lot Number: 3949868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1