MAUDE Adverse Event Report: CONVATEC, INC. NATURA DURA FLATMLD M 45MM; PROTECTOR, OSTOMY

Model Number 411802

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/20/2014

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Wife reports red bleeding skin under tape border.Using moisturizing soap.Discussed use of non-residue soap.Sending samples of 1 piece per request; advised to cut off tape border.Has been treating with calmoseptine ointment and non stick pad.Customer interaction center advised to crust with stomahesive powder and skin protectant barrier wipe and cut off tape border.Advised to contact health care provider if no improvement.

• Brand Name: NATURA DURA FLATMLD M 45MM
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5155885
• MDR Text Key: 28464988
• Report Number: 1049092-2015-30470
• Device Sequence Number: 1
• Product Code: EXE
• 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
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 12/08/2018
• Device Model Number: 411802
• Device Lot Number: 3M00118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2013
• 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