MAUDE Adverse Event Report: CONVATEC INC. ESTEEM® + ONE-PIECE DRAINABLE CUT-TO-FIT POUCH; POUCH, COLOSTOMY

Model Number 416719

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

Patient Problems Skin Discoloration (2074); Tissue Damage (2104); Discharge (2225)

Event Date 12/18/2014

Event Type  Injury  

Manufacturer Narrative

(b)(6) based on the available information, this event is deemed to be a serious injury.The post market trend analysis, subject matter expert (sme) review, clinical review, and marketing review indicate that a perception in specific markets has caused a consistent rate of complaints by the end user because there is no wear time requirement for the ostomy skin barrier.No further actions are required, and this complaint will be closed.Although physical samples were received, no evaluation will be conducted.This evaluation will be closed.This issue will be monitored through the post market product monitoring review process.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on november 17, 2016.(b)(4).

Event Description

Complaint reported that the "end user experienced a decrease in wear time from 1 to 2 times per day or up to 2 days max.He states due to frequent wafer changes he developed a 25mm open area with a red wound base between 4 and 7 o'clock that has mild clear drainage.He reports treating the area using stomahesive powder and liquid bandage and the area is improving.He states this occurred with 10 wafers from this box, and 7 wafers from a different box, but same lot." no further details have been provided.

• Brand Name: ESTEEM® + ONE-PIECE DRAINABLE CUT-TO-FIT POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6110271
• MDR Text Key: 60245187
• Report Number: 1049092-2016-00463
• 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: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/07/2019
• Device Model Number: 416719
• Device Lot Number: 4K00854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2014
• 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: HOLLISTER, ADHESIVE REMOVER; KETOPROFEN (UNKNOWN) CHOLESTEROL MEDICATION,; STOMAHESIVE POWDER, LIQUID BANDAGE,
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 159