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

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.

• Brand Name: 1PC-POUCH-ESTEEM+
• Type of Device: POUCH, COLOSTOMY
• MDR Report Key: 7498928
• MDR Text Key: 107743718
• Report Number: 3005778470-2018-00016
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421830
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR