MAUDE Adverse Event Report: ESTEEM +; POUCH, COLOSTOMY

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

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.

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).

• Brand Name: ESTEEM +
• Type of Device: POUCH, COLOSTOMY
• MDR Report Key: 6650535
• MDR Text Key: 77866153
• Report Number: 9618003-2017-00004
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2022
• Device Model Number: 416976
• Device Lot Number: 7A02383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/24/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 54