MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2018-10-15 for NEOTECH N720 manufactured by Neotech Products Llc.
[123743800]
Device was not returned and no evaluation is possible on the actual device. One device from the same lot number was returned by customer. Per our product engineer's report, there is no issue with the design of product which is intended to protect eyes during phototherapy session. Device affix to the patient head with two tabs to cover the eyes. The tabs are composed of medical grade hydrocolloid adhesive at one side to contact to skin and the velcro hooks at the other side to attach to neoshade which is made from velcro hooks adaptive fabric. The velcro hook type is just strong enough to secure neoshade on the patient's eyes during a full phototherapy session. It seems that the skin breakdown was caused by not following the direction of use for removing the product. This device has been in the market for about twenty years and comply with bio-compatibility requirements ((b)(4)). Neoshades are also available with head strap band which was designed to keep the device secure on patients with sensitive skin. This complaint will be monitored for trending purposes and is added to the related logs and charts.
Patient Sequence No: 1, Text Type: N, H10
[123743802]
Skin beakdown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025917-2018-00112 |
| MDR Report Key | 7966413 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2018-10-15 |
| Date of Report | 2018-10-15 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2017-11-28 |
| Date Added to Maude | 2018-10-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BEN MAHAJAN |
| Manufacturer Street | 28430 WITHERSPOON PKW |
| Manufacturer City | VALENCIA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6617757466 |
| Manufacturer G1 | NEOTECH PRODUCTSLLC |
| Manufacturer Street | 28430 WITHERSPOON PKW |
| Manufacturer City | VALENCIA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91355 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOTECH |
| Generic Name | NEOSHADES WITH TABS |
| Product Code | FOK |
| Date Received | 2018-10-15 |
| Model Number | N720 |
| Catalog Number | N720 |
| Lot Number | 2017-0952 |
| Device Expiration Date | 2019-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOTECH PRODUCTS LLC |
| Manufacturer Address | 28430 WITHERSPOON PARKWAY VALENCIA CA 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-15 |