MAUDE Adverse Event Report: CONVATEC INC. ESTEEM SYNERGY DURAHESIVE CONVEX MOLDABLE; POUCH, COLOSTOMY

Model Number 409272

Device Problem Difficult to Remove (1528)

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

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Additional information has been requested, however 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 11, 2016.Note: this complaint issue occurred on (b)(4) separate cases.A separate 3500a form has been completed for the other (b)(4) cases.

Event Description

It was reported the plate/wafer sticks too strongly.There was no harm reported.

Manufacturer Narrative

A batch record review was performed and indicates no discrepancies related to this complaint.Process checks and quality checks were performed with acceptable results.No additional action is required and this complaint will be closed.This issue will be monitored through the post market 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 september 15, 2016.(b)(4).

• Brand Name: ESTEEM SYNERGY DURAHESIVE CONVEX MOLDABLE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5783687
• MDR Text Key: 49204715
• Report Number: 1049092-2016-00307
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2021
• Device Model Number: 409272
• Device Lot Number: 6E01043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1