MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-09 for NEOSHADES PHOTOTHERAPY EYE SHIELDS N721 SMALL WITH TABS manufactured by Neotech Products, Inc..
[51498163]
Patient Sequence No: 1, Text Type: N, H10
[51498164]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5856176 |
| MDR Report Key | 5856176 |
| Date Received | 2016-08-09 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-05-17 |
| Report Date | 2016-08-01 |
| Date Reported to FDA | 2016-08-01 |
| Date Reported to Mfgr | 2016-08-01 |
| Date Added to Maude | 2016-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOSHADES PHOTOTHERAPY EYE SHIELDS |
| Generic Name | PAD, NEONATAL EYE |
| Product Code | FOK |
| Date Received | 2016-08-09 |
| Catalog Number | N721 SMALL WITH TABS |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOTECH PRODUCTS, INC. |
| Manufacturer Address | 27822 FREMONT COURT VALENCIA, CA 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-09 |