MAUDE Adverse Event Report: NEOTECH PRODUCTS, INC. NEOSHADES PHOTOTHERAPY EYE SHIELDS; PAD, NEONATAL EYE

Catalog Number N721 SMALL WITH TABS

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978); Protective Measures Problem (3015)

Patient Problem No Information (3190)

Event Date 05/17/2016

Event Type  malfunction  

Event Description

New eye protector mask for use under photo therapy lights (used for newborns/infants).Mask is not tight on face, allowing the newborn/infant's eyes to be exposed to photo therapy lights.Infant able to pull mask off easily.Having to throw away multiple masks due to not sticking appropriately after newborn repeatedly able to tear it off.About 10 or more masks thrown away/used in less than 24 hours on one newborn.Parent of newborn having to continuously monitor that mask is staying on.Skin breakdown (redness) from the sticky part of tabs used to hold mask in place (one side is adhesive and other is velcro).Bottom line 2 issues with this mask: 1.Inability for mask to stay on with infant movement, 2.Adhesive against skin to hold mask in place harsh on infant's skin.

• Brand Name: NEOSHADES PHOTOTHERAPY EYE SHIELDS
• Type of Device: PAD, NEONATAL EYE
• Manufacturer (Section D): NEOTECH PRODUCTS, INC.; 27822 fremont court; valencia, CA 91355
• MDR Report Key: 5856176
• MDR Text Key: 51498164
• Report Number: 5856176
• Device Sequence Number: 1
• Product Code: FOK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2016,08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: N721 SMALL WITH TABS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other