MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-25 for GLOOKO DEVICE SYSTEM manufactured by Glooko.
| Report Number | 3009137498-2019-00008 |
| MDR Report Key | 8827702 |
| Date Received | 2019-07-25 |
| Date of Report | 2019-07-25 |
| Date of Event | 2019-06-26 |
| Date Mfgr Received | 2019-06-26 |
| Date Added to Maude | 2019-07-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | TEJASVI PASI |
| Manufacturer Street | 303 BRYANT ST |
| Manufacturer City | MOUNTAIN VIEW CA 94041 |
| Manufacturer Country | US |
| Manufacturer Postal | 94041 |
| Manufacturer Phone | 6507205310 |
| Manufacturer G1 | GLOOKO |
| Manufacturer Street | 303 BRYANT ST |
| 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 | 0 |
| Brand Name | GLOOKO DEVICE SYSTEM |
| Generic Name | GLOOKO MOBILE APPLICATION |
| Product Code | PHV |
| Date Received | 2019-07-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOOKO |
| Manufacturer Address | 303 BRYANT ST MOUNTAIN VIEW CA 94041 US 94041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-25 |