MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC ESTEEM PCH DRNWFINVISICLR60/70MM; POUCH, COLOSTOMY

Model Number 416718

Device Problem Material Deformation (2976)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).Evaluation conclusions are reflected in the codes.

Event Description

Customer states the one piece pouch made a small cut near stoma on peristomal skin.Draining serous fluid.States began using stomahesive moldable wafer 411805 and cut is healing.

• Brand Name: ESTEEM PCH DRNWFINVISICLR60/70MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC; 18.5 parque industrial; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5138975
• MDR Text Key: 27898983
• Report Number: 9618003-2015-30387
• 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
• Reporter Occupation: Patient
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 113