MAUDE Adverse Event Report: CONVATEC INC. NATURA DURA FLATMLD 45/70MM; PROTECTOR, OSTOMY

Model Number 411806

Device Problem Leak/Splash (1354)

Patient Problems Pain (1994); Tissue Damage (2104)

Event Date 06/25/2014

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

It was reported that the customer service representative spoke with wife of the patient who is out of state.States husband cannot communicate and is unable to provide product info or a stoma description but said he is using a oval shaped 70mm wafer that leaves a small gap around stoma.Reported using unknown adhesive remover and barrier and stated customer was in pain upon removal with tearing of the skin.She was unsure if barrier and adhesive remover were sting free.Will follow up.He states he does not have lot number.Uses moldable wafer as precut.Uses safe and simple wipes and adhesive removers; adapt paste and barrier rings in different combinations.Leaking always occurs at 8 to 9 olcock near crease.Reviewed use of moldable and use of convexity with eakin slim to fill crease and use of belt.To call back if continued issues.Gets odor before leaking occurs; wafers last 2 to 3 days.Product use and skin care instructions provided.

• Brand Name: NATURA DURA FLATMLD 45/70MM
• 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: 5154247
• MDR Text Key: 28435700
• Report Number: 1049092-2015-30591
• 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: other
• Reporter Occupation: Other
• 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 Model Number: 411806
• 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
• 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