MAUDE Adverse Event Report: COLOPLAST A/S SILIC FOLEY CATH 5/15ML/5; SILICONE FOLEY CATHETER

Model Number AA61161002

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be filed should additional information become available.

Event Description

According to the information received, a catheter was inserted and subsequently fell out after 3 days.Per report, balloon appeared to have leaked.

• Brand Name: SILIC FOLEY CATH 5/15ML/5
• 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: 4371967
• MDR Text Key: 19049686
• Report Number: 9610711-2014-00038
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/01/2014,12/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2019
• Device Model Number: AA61161002
• Device Catalogue Number: AA61161002
• Device Lot Number: 4132078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: No
• Date Report to Manufacturer: 12/01/2014
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/30/2014
• Date Device Manufactured: 02/20/2014
• 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): Other