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

Model Number 416976

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

Patient Problems Erythema (1840); Itching Sensation (1943); Burning Sensation (2146); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.No sample was returned for analysis and no lot number was provided.An analysis of trends for complaints of this nature showed no trends that would conclude the product did not meet specification, perform as intended and/or identify a root cause.No further actions are required, and the complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Should additional information become available a follow-up report will be submitted.

Event Description

End user reported that for 2 weeks or so she has had red, itching and burning skin under the mass and tape collar.She further reported pustules are scattered to the area as well.She has been prescribed nystatin powder and an unknown antibiotic.

• 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: 5386641
• MDR Text Key: 36687341
• Report Number: 9618003-2016-00004
• 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: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2015
• 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
• Treatment: TEGRATOL
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 44