MAUDE Adverse Event Report: CONVATEC INC. NATURA 2 PC DURAHESIVE MOLDABLE WAFER; PROTECTOR, OSTOMY

Model Number 411804

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/16/2013

Event Type  Injury  

Event Description

End-user reported several month history of open areas directly around the stoma.It is reported that end-user has been using kenalog spray to treat these open areas without success.

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury.It is reported that end-user uses an (b)(4) ring to help prevent leaking, but does not mold wafer.End-user uses wafer and protective barrier wipes as well as adhesive remover wipes and perform wafer changes every three (3) to four (4) days or when he feels it stinging.Skincare was reviewed with end-user who was advised to stop using the (b)(4) spray and to use (b)(4) powder with protective wipes and blot.Proper usage of the moldable wafer was also reviewed with end-user, and samples of the smaller size moldable wafer has been sent to end-user.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information becomes available, a follow-up report will be submitted.Note: the actual date of event is unknown, so the date used was the date convatec became aware.

• Brand Name: NATURA 2 PC DURAHESIVE MOLDABLE WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: mary szaro, associate dir. ; 200 headquarters park drive; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3594823
• MDR Text Key: 17388061
• Report Number: 1049092-2014-00032
• Device Sequence Number: 1
• Product Code: EXB
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 411804
• Device Catalogue Number: 411804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2013
• Initial Date FDA Received: 01/13/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 72