MAUDE Adverse Event Report: CONVATEC INC. ESTEEM® + DRAINABLE POUCH EXTENDED WEAR; POUCH, COLOSTOMY

Model Number 416975

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

Patient Problems Skin Inflammation (2443); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted (b)(4).

Event Description

End user reports about a month ago when trying the product out, he experienced red, puffy and weepy skin where the pouch adhesive had been in contact with his skin after 3 days of wear.He washed the skin with water and applied and switched to a competitor's product.He also sought treatment from a physician and was prescribed a steroidal cream (unknown name) to be applied when pouch was changed.End user states his skin was back to normal within 5 days of applying the steroid cream.

• Brand Name: ESTEEM® + DRAINABLE POUCH EXTENDED WEAR
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; arque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5295482
• MDR Text Key: 33452573
• Report Number: 9618003-2015-00065
• 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
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2015
• 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 Age: 42 YR
• Patient Weight: 86