MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-06-20 for LIVONGO SCALE BT004L FG04087 manufactured by Livongo Health, Inc.
| Report Number | 3011196194-2019-00007 |
| MDR Report Key | 8718811 |
| Report Source | CONSUMER |
| Date Received | 2019-06-20 |
| Date of Report | 2019-06-20 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2019-06-01 |
| Device Manufacturer Date | 2019-01-28 |
| Date Added to Maude | 2019-06-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MICHAEL CHIBBARO |
| Manufacturer Street | 150 W. EVELYN AVE SUITE 150 |
| Manufacturer City | MOUNTAIN VIEW CA 94041 |
| Manufacturer Country | US |
| Manufacturer Postal | 94041 |
| Manufacturer Phone | 4087185657 |
| Manufacturer G1 | LIVONGO HEALTH, INC |
| Manufacturer Street | 150 W EVELYN AVES SUITE 150 |
| Manufacturer City | MOUNTAIN VIEW CA 94041 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIVONGO SCALE |
| Generic Name | SCALE |
| Product Code | FRI |
| Date Received | 2019-06-20 |
| Model Number | BT004L |
| Catalog Number | FG04087 |
| Lot Number | 1905 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVONGO HEALTH, INC |
| Manufacturer Address | 150 W EVELYN AVE SUITE 150 MOUNTAIN VIEW CA 94041 US 94041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-20 |