MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE ONE-PIEVE DRAINABLE CUT-TOFIT POU; POUCH, COLOSTOMY

Model Number 022771

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Event Description

The end user reported that for several months she experienced a rash that is red and itchy under the skin barrier of the one-piece device.The rash is reportedly spreading in several areas.The end user sought treatment from her physician and was prescribed clotrimazole ointment.No further info was provided.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No add'l p/event details have been provided to date.Should add'l info become available, a follow up report will be submitted.

• Brand Name: ACTIVELIFE ONE-PIEVE DRAINABLE CUT-TOFIT POU
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina 3 ; DR 3
• Manufacturer Contact: matthew walenciak, interim associ ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4755507
• MDR Text Key: 5771001
• Report Number: 9618003-2015-00023
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/28/2015

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 Model Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/06/2015
• 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: Initial
• Patient Sequence Number: 1
• Treatment: CELEXA,; LOTRAMINE SPRAY,
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 73