MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,health p report with the FDA on 2020-02-20 for NOXBOXI manufactured by Noxbox, Ltd.
| Report Number | 3012796317-2020-00001 |
| MDR Report Key | 9732356 |
| Report Source | CONSUMER,DISTRIBUTOR,HEALTH P |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-20 |
| 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 | KAREN RING |
| Manufacturer Street | 1081 GALLEY DRIVE KENT SCIENCE PARK |
| Manufacturer City | SITTINGBOURNE, KENT ME9 8GA |
| Manufacturer Country | UK |
| Manufacturer Postal | ME9 8GA |
| Manufacturer G1 | NOXBOX, LTD |
| Manufacturer Street | 1081 GALLEY DRIVE KENT SCIENCE PARK |
| Manufacturer City | SITTINGBOURNE, KENT ME9 8GA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | ME9 8GA |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOXBOXI |
| Generic Name | NITRIC OXIDE ADMINISTRATION APPARATUS |
| Product Code | MRN |
| Date Received | 2020-02-20 |
| Returned To Mfg | 2020-02-13 |
| Model Number | NOXBOXI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOXBOX, LTD |
| Manufacturer Address | 1081 GALLEY DRIVE KENT SCIENCE PARK SITTINGBOURNE, KENT ME9 8GA UK ME9 8GA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |