MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE® ONE-PIECE PRE-CUT DRAINABLE POUCH; BAG, URINARY, ILEOSTOMY

Model Number 022758

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

Patient Problems Erythema (1840); Irritation (1941); Itching Sensation (1943)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a serious injury.His 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.Reported to the fda on may 26, 2016.(b)(4).

Event Description

The end user reported that he developed red, irritated, itchy skin around his stoma where the tape collar comes into contact with his skin.This first occurred about a year ago.He saw his dermatologist several months ago, who prescribed a topical spray (not otherwise specified).According to the end user, the spray did not help clear up his skin, and affected wafer adhesion, so he quit using it.He has been trimming the tape collar from his pouches for the past month and the skin is now slowly beginning to improve, but is not fully resolved.

• Brand Name: ACTIVELIFE® ONE-PIECE PRE-CUT DRAINABLE POUCH
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; parque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5682581
• MDR Text Key: 46022278
• Report Number: 9618003-2016-00024
• Device Sequence Number: 1
• Product Code: EXH
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: METHIMAZOLE
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 88