MAUDE Adverse Event Report: CONVATEC INC TRIO; PROTECTOR, OSTOMY

Model Number 423392

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Fungal Infection (2419); Tissue Breakdown (2681); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

The end user reported that skin breakdown and irritation from company's two different products.She was unable to determine what was causing irritation and breakdown between these two products.It had been ongoing issue for the last three to four months.She was still using the product.Also, the end user stated that she had used the company's adhesive remover and barrier wipes prior without any issue.Further, she reported that she was seen by dermatologist five (05) times for skin irritation and breakdown.The dermatologist determined that the infection was fungal.In addition to this, consumer reported multiple open areas, denied bleeding at this time and stated some areas were raised and the peristomal skin was painful.The end user used ketoconazole cream two (02) times daily, hydrocortisone cream 2.5 as needed (prn), ciclopirox cream 0.77% two (02) times daily.All these creams which are ketoconazole, hydrocortisone, and ciclopirox have been stopped.However, she is using doxycycline two (02) times daily oral for thirty (30) days and diflucan which is now oral for five (05) days a week.Treatment is ongoing.She has been seen by wound care.She now washes the peristomal skin with baby shampoo and applies company's known dressing prior to applying ostomy pouch.Further, she was using company's pouch with the wipes when this issue occurred.  no other products were used.Also, reported that her skin was improving and stopped using the wipes since she has a sensitivity to them.Now, it is her opinion that she is sensitive to the wipes and she is no longer using them.A photograph depicting the issue was received from the complainant.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: TRIO
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; suite 400; 7900 triad center drive; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 16634827
• MDR Text Key: 312197371
• Report Number: 1049092-2023-00032
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 423392
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ADHESIVE REMOVER WIPE.; COMPANY'S POUCH.
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female