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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 416976
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Fungal Infection (2419)
Event Type  Injury  
Manufacturer Narrative
A batch record review for lot# 7a02383, was performed. The batch record review supports that there were no discrepancies during the manufacturing of lot 7a02383. A previous investigation is applicable to this complaint. The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is a result of skin complications caused by a variety of external factors not related to the design, materials, and/or processes of the product. No further actions are required. 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. (b)(4).
 
Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.   no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
 
Event Description
Daughter of end user calls to report a rash under the tape collar that the end user has had for several months. End user has been placing nystatin cream as prescribed by her health care physician to the area. She was also prescribed diflucan oral medication 2 weeks ago by her doctor. She states the rash starts to improve after taking the medication but then comes right back. On 05/30/2017 additional information was received by the end user's daughter that another 10-day dose of diflucan was prescribed and that the end user was diagnosed with chronic yeast infection that was also in her stool. End user received samples of the diflucan, however she had not started on them yet.
 
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Brand NameESTEEM +
Type of DevicePOUCH, COLOSTOMY
MDR Report Key6650535
MDR Text Key113526941
Report Number9618003-2017-00004
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,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/19/2022
Device Model Number416976
Device Lot Number7A02383
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received08/24/2017
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: 06/19/2017 Patient Sequence Number: 1
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