MAUDE Adverse Event Report: CONVATEC ESTEEM+ FLEX CONVEX

Model Number 421619

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Pain (1994)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Common device name: pouch, colostomy.Based on the available information, this event is deemed to be a serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Additional patient / event details have been requested but, not provided to date.The lot number was not provided.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

It was reported open sore to the left side of her stoma that towards umbilicus, that became very painful.It was described as open ulcer at 3 o¿clock, approximately ¾¿ in diameter and extends from side wall of stoma to peristomal skin.She also has a raw area on the right side of her stoma at 9 o¿clock, that had not progressed to an open sore.She went to the emergency room on (b)(6) 2019 and was diagnosed with cellulitis, and given a prescription for keflex.She then had a follow up with her surgeon, and was seen by an ostomy nurse at the surgeon¿s office on (b)(6) 2019, who instructed her to crust the areas, and recommended she switch to esteem + one piece drainable pouch with moldable barrier.She further reports she has almost completed the keflex, the open ulcer at 3 o¿clock is no longer painful, and the raw area at 9 o¿clock has almost fully resolved.The end user informed at the time of her ileostomy surgery her stoma was 35mm and she was wearing esteem+ flex convex.Over the last few months, her stoma has prolapsed and the diameter has increased to 38mm.She continued to wear the esteem+ flex convex but, reported that she was cutting the opening beyond the maximum cutting surface.The end user was instructed to avoid convexity, and not to cut beyond the maximum cutting surface marked on any pouch barriers.No photographs were provided.

• Brand Name: ESTEEM+ FLEX CONVEX
• Manufacturer (Section D): CONVATEC; 7900 triad center drive; suite 400; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 7900 triad center drive; suite 400; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 8807758
• MDR Text Key: 151602485
• Report Number: 1049092-2019-00206
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421619
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63