MAUDE Adverse Event Report: CONVATEC, INC ESTEEM + CONVEX ONE-PIECE DRAINABLE PRE-CUT; POUCH, COLOSTOMY

Model Number 416744

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

Patient Problems Erythema (1840); Pain (1994); Skin Irritation (2076); Burning Sensation (2146)

Event Date 01/06/2015

Event Type  Injury  

Event Description

End user reports that his skin is red and irritated along with burning that extends approximately one half inch around the stoma and the redness extends out one inch.He also stated that effluent comes from both openings, the ostomy and the fistula.He stated that he has had this skin irritated since his surgery in (b)(6), where he had a revision of his stoma due to the fistula, but the revision failed.The end user stated he was prescribed topical lidocaine for peristomal skin and that he uses wafers to filler.He was instructed to fill in gaps between opening and stoma with wafers and not to cover the fistula opening.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No further info was available at the time of the report.Should additional info become available, a f/u report will be submitted.(b)(4).

Manufacturer Narrative

The product associated with batch 4a02421 was made according to specification.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Previous investigation,is applicable to this complaint investigation.This previous investigation is open.Therefore, this complaint will remain open until completion of the previous investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Previous non-conformance is applicable to this complaint and is closed.No further actions are required, and this complaint will be closed.The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is a result of skin complications caused by a variety of external factors not related to the design, materials, and/or processes of the product.No additional event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ESTEEM + CONVEX ONE-PIECE DRAINABLE PRE-CUT
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 4626159
• MDR Text Key: 5760060
• Report Number: 1049092-2015-00166
• 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,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2019
• Device Model Number: 416744
• Device Lot Number: 4A02421
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 65 YR