MAUDE Adverse Event Report: CONVATEC INC. NATURA DURAHESIVE FLEXIBLE SKIN BARRIER; PROTECTOR, OSTOMY

Model Number 413161

Device Problem Material Discolored (1170)

Patient Problems Erythema (1840); Skin Irritation (2076)

Event Type  malfunction  

Manufacturer Narrative

Height (b)(6).Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that after wearing the product for seven days, the end user experienced redness on the peristomal skin under the white tape collar which started to migrate under the mass at the edge.There was also a black discoloration on the wafer where the mass and tape collar meet.It was also reported that the end user picture frames the wafer using hypafix tape.During a recent patient visit the ostomy nurse stated that the redness could be caused by the hypafix tape and the patient was advised to discontinue it's use.

Manufacturer Narrative

Based on further evaluation and review of the reported event, it has been determined that this is a non-reportable event.The initial mdr submitted on march 25, 2016 (mdr# 1049092-2016-00112) was submitted in error.Therefore, a retraction is being submitted for the initial mdr (mdr# 1049092-2016-00112).No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: NATURA DURAHESIVE FLEXIBLE SKIN BARRIER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5526843
• MDR Text Key: 41215652
• Report Number: 1049092-2016-00112
• 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,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 413161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 86