MAUDE Adverse Event Report: CONVATEC INC. NATURA + CLOSED END POUCH WITH FILTER, OPAQUE; POUCH, COLOSTOMY

Model Number 125907

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/05/2014

Event Type  malfunction  

Event Description

The end user reported moisture has developed on the wafer outside of the pouch at the point of ring due to an incomplete connection/seal between the pouch and wafer.No pt consequences were reported as a result of this event.

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.No add'l pt/event details have been provided to date.Should add'l info become available, a f/u report will be submitted.A return sample for eval is not expected.

Manufacturer Narrative

The nonconformance (nc) associated with this complaint issue has been approved and is complete.Investigation findings conclude there are several contributing factors for the reported issue including personnel, materials, machine and methods.The necessary actions have been taken to address these factors.No additional action is required and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on july 15, 2016.(b)(4).

• Brand Name: NATURA + CLOSED END POUCH WITH FILTER, OPAQUE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; haina, san cristobal, ; DR
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4324818
• MDR Text Key: 5136136
• Report Number: 9618003-2014-00102
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 11/05/2014

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: Lay User/Patient
• Device Model Number: 125907
• Device Lot Number: 4C03159
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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