MAUDE Adverse Event Report: CONVATEC INC. NATURA WFR FLEX 45MM TAN; PROTECTOR, OSTOMY

Model Number 125264

Device Problem Leak/Splash (1354)

Patient Problems Tissue Damage (2104); Tissue Breakdown (2681)

Event Date 06/10/2014

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Reports skin denudement; weeping and bleeding intermittently since (b)(6) 2014.Has tried different 2pc and 1 pc systems with leaking of stool which causes poor weartime.Wafers have been lasting 24 hrs or less.Using babywipes only.Advised to start crusting with stomahesive powder and blotting with protective wipe or finger dipped in water in 2 to 3 layers.Product use and skin care instructions provided _ advised stomahesive powder and crusting technique and to stop using baby wipes.

• Brand Name: NATURA WFR FLEX 45MM TAN
• 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: 5154010
• MDR Text Key: 28435810
• Report Number: 1049092-2015-30576
• 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
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: 125264
• Device Lot Number: 4D02720
• 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: 05/01/2014
• 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: 82