MAUDE Adverse Event Report: ESTEEM +; POUCH, COLOSTOMY

Model Number 416718

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

Patient Problems Abrasion (1689); Skin Discoloration (2074); Fungal Infection (2419)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

Based on the available information, the event is deemed to be a reportable serious injury.A query was run on october 31, 2017 against lot number 7d03907 for the reported event, and yielded 1 occurrence (s) against the lot.At this time, a detailed investigation or batch review is not required.If additional complaints occur with the batch criteria and same reported event, any subsequent complaints shall be assessed for further investigation at that time.This issue will be monitored through the post market product monitoring review process.Additional information has been requested but has not been received to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

It was reported by the end user that when she removed the one-piece pouch, a layer of skin came off with the device that was in the shape of the mass.There was redness but no bleeding or drainage.The end user saw a physician who diagnosed a fungal infection and prescribed cefalexin and a antifungal powder (brand unknown).The end user states the affected area remains red but has improved.The end user remains on antibiotics and powder for the infection.She did not feel the skin barrier was difficult to remove initially when the layer of skin came off with the mass, but rather the result of the infection underneath.The end user states that her removal technique includes an adhesive remover, and "it comes right off." the end user has a follow up visit with the hcp within the week.No further details have been provided.

• Brand Name: ESTEEM +
• Type of Device: POUCH, COLOSTOMY
• MDR Report Key: 7022982
• MDR Text Key: 91855672
• Report Number: 3005778470-2017-00011
• 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: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2022
• Device Model Number: 416718
• Device Lot Number: 7D03907
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR