MAUDE Adverse Event Report: CONVATEC, INC. SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER; PROTECTOR, OSTOMY, 78 EXE

Model Number 413183

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Skin Tears (2516)

Event Date 05/25/2014

Event Type  Injury  

Event Description

It is reported that end-user's peristomal area has red open skin that bleeds occasionally and measures approx.32 mm at the 7 o'clock position after using the product for three (3) days.

Manufacturer Narrative

Treatment included care of a wound ostomy & continence care nurse ((b)(6)), aquacel ag dressing, allevyn dressing, medihoney (leptospermum scoparium), and stomahesive powder.Based on the avail info, this event is deemed to be a serious injury.No add'l pt/event details have been provided to date.A return sample for eval is not expected.Should add'l info become available, a follow-up report will be submitted.

Manufacturer Narrative

The product associated with batch 2g03148 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.Reported to the fda on: (b)(6) 2016.(b)(4).

• Brand Name: SUR-FIT NATURA 2 PC DURAHESIVE CONVEX WAFER
• Type of Device: PROTECTOR, OSTOMY, 78 EXE
• 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: 4059084
• MDR Text Key: 18071092
• Report Number: 1049092-2014-00406
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K855018
• 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: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2017
• Device Model Number: 413183
• Device Catalogue Number: 413183
• Device Lot Number: 2G03148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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