MAUDE Adverse Event Report: CONVATEC INC. NATURA WFR FLEX 70MM WHT; PROTECTOR, OSTOMY

Model Number 125261

Device Problem Material Separation (1562)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to convatec remediation protocol (b)(4) and 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

End user reports he had slight bleeding of the stoma after what he initially described as the mass delaminating from the skirting of flange and the mass sliding down exposing the skirting to dig into the stoma.The end user reports removing the product and applying light pressure to stoma for a few minutes and it would stop.During a follow-up discussion, it was clarified that the issue was erosion of the wafer, not delamination.Additionally, it was determined that the end user was wearing a larger flange than necessary, and cutting the wafer with scissors, sometimes leaving a ragged edge.Use of appropriate products discussed.

• Brand Name: NATURA WFR FLEX 70MM WHT
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5288622
• MDR Text Key: 33247758
• Report Number: 1049092-2015-40092
• 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
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/28/2017
• Device Model Number: 125261
• Device Lot Number: 2F01147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2012
• 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 Weight: 73