MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-24 for SLEEP 8 CPAP SANITIZING COMPANION SLP82043 UNK manufactured by Sleep 8, Inc.
| Report Number | 3014439254-2019-00001 |
| MDR Report Key | 8729109 |
| Date Received | 2019-06-24 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-04-29 |
| Date Added to Maude | 2019-06-24 |
| 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 | MR JORDAN SOBLICK |
| Manufacturer Street | 1569 MALLORY LANE BLDG 100 |
| Manufacturer City | BRENTWOOD TN 37027 |
| Manufacturer Country | US |
| Manufacturer Postal | 37027 |
| Manufacturer Phone | 5614410906 |
| Manufacturer G1 | SLEEP 8, INC |
| Manufacturer Street | 1569 MALLORY LANE BLDG 100 |
| Manufacturer City | BRENTWOOD TN 37027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SLEEP 8 CPAP SANITIZING COMPANION |
| Generic Name | CPAP CLEANER |
| Product Code | LRJ |
| Date Received | 2019-06-24 |
| Model Number | SLP82043 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SLEEP 8, INC |
| Manufacturer Address | 1569 MALLORY LANE BLDG 100 BRENTWOOD TN 37027 US 37027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-24 |