MAUDE Adverse Event Report: CONVATEC LIMITED ESTEEM SYNERGY STANDARD CLOSED END POUCH; POUCH, CLOSTOMY

Model Number 409282

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Skin Tears (2516); Blood Loss (2597)

Event Type  malfunction  

Event Description

The end user reported the pouches are cutting into his stoma causing it to bleed for a few minutes.The cut measures approximately one cm in length.He stated that there is no blood on any part of the pouch or the inner rim after bleeding from the cut is noticed.He further stated that he went back to the former pouch and did not have any bleeding.The end user was advised to apply pressure and to follow-up with his health care provider if the bleeding does not stop.He was also educated on the features of pouch and adhesive technology.

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.No additional pt/event details have been provided to date.Should additional info become available, a follow-up report will be submitted.(b)(6).

Manufacturer Narrative

Based on additional info received on 04/13/2015, product sample was received.An investigation is pending.No additional patient/event details have been provided to date.Should additional info becomes available, a follow up report will be submitted.Reported to the fda on (b)(6) 2015.

Manufacturer Narrative

Additional information received november 11, 2015.No previous investigations are available.After a detailed batch review, no discrepancies were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.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 november 25, 2015.(b)(4).

• Brand Name: ESTEEM SYNERGY STANDARD CLOSED END POUCH
• Type of Device: POUCH, CLOSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; unit 20, first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 4549519
• MDR Text Key: 5527149
• Report Number: 1000317571-2015-00007
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Model Number: 409282
• Device Lot Number: 4F00804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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
• Treatment: LEFLUNOMIDE; PREDNISONE
• Patient Age: 49 YR
• Patient Weight: 75