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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 1PC-POUCH-ESTEEM+ POUCH, COLOSTOMY

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1PC-POUCH-ESTEEM+ POUCH, COLOSTOMY Back to Search Results
Model Number 421830
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)
Event Date 04/13/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). Based on the available information, this event is deemed to be a serious injury. 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. Additional patient/event details have been requested but none have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
 
Event Description
It was reported that the end user had been using the esteem pouch since 2011, but then changed to an esteem + pouch with windows. The end user stated three (3) days after applying the esteem + wafer, she experienced full body itching, and a rash under the stomahesive mass. The surgeon indicated that the itching was due to the new adhesive pouch and advised the end user to return to the pouch used previously, but additional information received notes that the end user used all 30 pieces; device was used 1 x day for 30 days. The end user then returned to the pouch used previously. No medical interventions or treatments were required. No photographs were available. Although requested, no additional information was provided.
 
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Brand Name1PC-POUCH-ESTEEM+
Type of DevicePOUCH, COLOSTOMY
MDR Report Key7498928
MDR Text Key107743718
Report Number3005778470-2018-00016
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,foreign
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number421830
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 Received04/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/09/2018 Patient Sequence Number: 1
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