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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ESTEEM + POUCH, COLOSTOMY

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ESTEEM + POUCH, COLOSTOMY Back to Search Results
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.
 
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Brand NameESTEEM +
Type of DevicePOUCH, COLOSTOMY
MDR Report Key7022982
MDR Text Key91855672
Report Number3005778470-2017-00011
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/22/2022
Device Model Number416718
Device Lot Number7D03907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/23/2017
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

Patient Treatment Data
Date Received: 11/10/2017 Patient Sequence Number: 1
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