MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE 1 PC UROSTOMY CONVEX POUCH W/DH; BAG, URINARY, ILEOSTOMY

Model Number 125356

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

Patient Problems Pain (1994); Ulceration (2116); Burning Sensation (2146)

Event Date 10/01/2014

Event Type  Injury  

Event Description

It was reported by the end user of 2 small shallow ulcers at 12 and 6 o'clock area under mass, each about 5mm x 10mm, with pink moist wound bed.End user states they are painful and burn.Had seen using stomahesive paste but has discontinued use.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.End user states he has not seen his doctor nor wound ostomy continence nurse.End user further reports he had a sore once in the past and was given a compounded ointment of hydrocortisone and neosporin that he used, however, he saw no improvement.Discussed use of stomahesive powder and avoiding pressure.Will send sample of appliance with flat skin barrier.If no improvement end user will speak to his health care physician.No pt/event details has been provided to date.Should add'l info become available, a f/u report will be submitted.Reported to the fda on (b)(4) 2014.

Manufacturer Narrative

The product associated with batch 4d02401 was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.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: ACTIVELIFE 1 PC UROSTOMY CONVEX POUCH W/DH
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4193180
• MDR Text Key: 5099418
• Report Number: 1049092-2014-00555
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/22/2019
• Device Model Number: 125356
• Device Catalogue Number: 125356
• Device Lot Number: 4D02401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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 Weight: 84