MAUDE Adverse Event Report: CONVATEC INC. ESTEEM 1 PC DRAINABLE INVISICLOSE POUCH; PROTECTOR, OSTOMY

Model Number 416976

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

Patient Problems Tissue Damage (2104); Fungal Infection (2419); Skin Inflammation (2443)

Event Date 09/15/2014

Event Type  Injury  

Event Description

It is reported the end-user developed yellow pus filled blisters on her abdomen in the skin folds and under the mass and tape collar that was diagnosed as a yeast infection.

Manufacturer Narrative

On (b)(6) 2014, the end-user underwent a colostomy in the right lower abdomen and a colostomy appliance was placed in the operating room at the time of the procedure.She was on antibiotic therapy from (b)(6) 2014 as prophylactic treatment for the surgery.During this course of antibiotics, the end-user developed oral thrush in her mouth and was placed on nystatin swish and swallow and oral diflucan (fluconazole) and one (1) tablet by mouth for two (2) courses.While on the second course of diflucan treatment, per her physician, she developed a yeast infection in a skin fold of abdomen that extended to under the mass and tape collar.After receiving the second course of diflucan, the oral thrush had resolved but the skin fold had not.The physician placed the end-user on another course of oral diflucan and ordered nystatin powder.The rash seemed to be improving.The end-user reported that she removes her appliance with sensi-care adhesive remover wipes and washes her skin with mild ivory soap and water.She then pats the area dry and applies nystatin powder.She dusts the excess powder and blots with sensi-care protective barrier wipes and allows drying.When dry, she applies the pouch.Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Reported to the fda on 10/13/2014.

Manufacturer Narrative

This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ESTEEM 1 PC DRAINABLE INVISICLOSE POUCH
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a. ; haina, san cristobal ; DR
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4179874
• MDR Text Key: 16635454
• Report Number: 9618003-2014-00088
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2018
• Device Model Number: 416976
• Device Catalogue Number: 416976
• Device Lot Number: 3J00721
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 56