MAUDE Adverse Event Report: CONVATEC, INC. S4S/SUR-FIT NATURA 2 PC DURAHESIVE (DH); SUR-FIT NATURA-DURAHESIVE CONVEX W, 78

Model Number 413180

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

Patient Problems Rash (2033); Skin Discoloration (2074)

Event Date 09/16/2014

Event Type  Injury  

Event Description

It was reported by the caregiver, the end user exhibited a red, intact rash to the peristomal area in the right lower quadrant.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.Current skincare includes using sensicare adhesive releaser; sensicare adhesive remover; water; and eakin.The end user is applying topical clobetasol propionate cream to peristomal rash which is covered with duoderm extra thin just in the last twelve (12) hours.The end user was instructed on appropriate skin care and will cut away tape collar and sample active life (al) convex urostomy appliance.End user was encouraged to follow up with a health care professional (hcp) if concerns persist or worsen.She is using marlen product to manage ileostomy.No patient/event details has been provided to date.Should additional info become available, a follow-up report will be submitted.

Manufacturer Narrative

The product associated with batch 3a01849 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.(b)(4).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 march 14, 2016.(b)(4).

• Brand Name: S4S/SUR-FIT NATURA 2 PC DURAHESIVE (DH)
• Type of Device: SUR-FIT NATURA-DURAHESIVE CONVEX W, 78
• 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: 4227902
• MDR Text Key: 4997069
• Report Number: 1049092-2014-00540
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833605
• 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: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2018
• Device Model Number: 413180
• Device Catalogue Number: 413180
• Device Lot Number: 3A01849
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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: 73