MAUDE Adverse Event Report: NEOTECH NEOTECH; NEOSHADES WITH TABS

Model Number N721

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

Device was not returned and no evaluation is possible on the actual device.In our investigation and follow-up with the reporting facility, the reporter (b)(6) the clinical effectiveness-data management, stated that it was the first time the nurses had tried to use the product as they had some samples.She also could not speak to whether the dfu was referred prior to use or not.There is a great probability that the nurses did not read the direction of use regarding proper activation of the adhesive before use, otherwise the part would not come off the face.This line of product is biocompatible per pbl report# (b)(4).It seems that the skin redness was caused by not following the direction of use for removing the product.(b)(6) also informed us that the baby was not harmed and has been discharged.This complaint will be monitored for trending purposes and is added to the related logs and charts.Device was not returned.

Event Description

Instability of mask and skin redness.

• Brand Name: NEOTECH
• Type of Device: NEOSHADES WITH TABS
• Manufacturer (Section D): NEOTECH; 28430 witherspoon parkway; valencia 91355
• Manufacturer (Section G): NEOTECH PRODUCTS, INC.; 28430 witherspoon pkw; valencia 91355
• Manufacturer Contact: leo arya ; 28430 witherspoon pkw; valencia 91355 ; 6617757466
• MDR Report Key: 6147760
• MDR Text Key: 62127965
• Report Number: 2025917-2016-00109
• Device Sequence Number: 1
• Product Code: FOK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N721
• Device Catalogue Number: N721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other