MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-06 for PROSOMNUS [IA] DEVICE 1020 manufactured by Prosomnus Sleep Technologies.
| Report Number | 3013116677-2019-00001 |
| MDR Report Key | 8674828 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-06-06 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-05-08 |
| Date Mfgr Received | 2019-05-08 |
| Device Manufacturer Date | 2017-07-19 |
| Date Added to Maude | 2019-06-06 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. DAVID KUHNS |
| Manufacturer Street | 5860 WEST LAS POSITAS BLVD SUITE 25 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 8445375337 |
| Manufacturer G1 | PROSOMNUS SLEEP TECHNOLOGIES |
| Manufacturer Street | 5860 WEST LAS POSITAS BLVD SUITE 25 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSOMNUS [IA] DEVICE |
| Generic Name | MICRO2 OBSTRUCTIVE SLEEP APNEA DEVICE |
| Product Code | LRK |
| Date Received | 2019-06-06 |
| Catalog Number | 1020 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROSOMNUS SLEEP TECHNOLOGIES |
| Manufacturer Address | 5860 WEST LASPOSITAS BLVD SUITE 25 PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-06 |