MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC ESTEEM PCH CLD WF STD TAN 50MM; POUCH, COLOSTOMY

Model Number 416715

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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 2015-001-pro and protocol 2015-002-pro.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).

Event Description

Customer states has been using above precut pouches to 50mm but stoma is now 28mm.States peristomal skin is bleeding and open.Advised to use stomahesive powder to crust area.Sending no sting sensicare wipes and samples precut to correct size.

• Brand Name: ESTEEM PCH CLD WF STD TAN 50MM
• 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: 5144424
• MDR Text Key: 28027649
• Report Number: 9618003-2015-30389
• 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: Other
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416715
• Was Device Available for Evaluation?: 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: 54