MAUDE Adverse Event Report: NATURA; PROTECTOR, OSTOMY

Model Number 411805

Device Problems Material Separation (1562); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).Based on the available information, this event is deemed to be a reportable malfunction.Additional patient/event details have been requested but none have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

The end user reported that after one day of wearing the skin barrier, ¿adhesive on pouch was splitting whilst in use.¿ it was reported that at the inner ring of the barrier, the layers separated, exposing the inner layer of the barrier.There was no harm to the end user and no medical intervention was required.The skin barrier was removed and replaced with the same product.No photographs are available.

Manufacturer Narrative

A review of the last three (3) product monitoring reports (pmr's) for trends, indicated no trends for the reported event for the product.Historical complaint data from (b)(6) 2015 to 2017 was reviewed as it related to the reported event for model# 411805.A total of (1) complaint, including this one, was reported.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been requested but none have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: NATURA
• Type of Device: PROTECTOR, OSTOMY
• MDR Report Key: 6766094
• MDR Text Key: 81906602
• Report Number: 1049092-2017-00044
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/27/2021
• Device Model Number: 411805
• Device Lot Number: 6F02869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1