MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-28 for NEOTECH PRODUCTS N709 manufactured by Neotech Products Llc.
| Report Number | 2025917-2019-00003 |
| MDR Report Key | 8941535 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-08-28 |
| Date of Report | 2019-08-28 |
| Date Mfgr Received | 2019-08-05 |
| Device Manufacturer Date | 2018-10-01 |
| Date Added to Maude | 2019-08-28 |
| 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 | BEN MAHAJAN |
| Manufacturer Street | 28430 WITHERSPOON PARKWAY |
| Manufacturer City | VALENCIA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6617757466 |
| Manufacturer G1 | NEOTECH PRODUCTS LLC |
| Manufacturer Street | 28430 WITHERSPOON PARKWAY |
| Manufacturer City | VALENCIA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91355 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOTECH PRODUCTS |
| Generic Name | NEOBAR |
| Product Code | CBH |
| Date Received | 2019-08-28 |
| Model Number | N709 |
| Catalog Number | N709 |
| Lot Number | 2019-0451 |
| 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 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-28 |