MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-06 for NEOTECH N721 manufactured by Neotech.
[62127965]
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.
Patient Sequence No: 1, Text Type: N, H10
[62127966]
Instability of mask and skin redness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025917-2016-00109 |
| MDR Report Key | 6147760 |
| Date Received | 2016-12-06 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-05-17 |
| Date Mfgr Received | 2016-08-15 |
| Date Added to Maude | 2016-12-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LEO ARYA |
| Manufacturer Street | 28430 WITHERSPOON PKW |
| Manufacturer City | VALENCIA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6617757466 |
| Manufacturer G1 | NEOTECH PRODUCTS, INC. |
| Manufacturer Street | 28430 WITHERSPOON PKW |
| Manufacturer City | VALENCIA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91355 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEOTECH |
| Generic Name | NEOSHADES WITH TABS |
| Product Code | FOK |
| Date Received | 2016-12-06 |
| Model Number | N721 |
| Catalog Number | N721 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOTECH |
| Manufacturer Address | 28430 WITHERSPOON PARKWAY VALENCIA 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-06 |