MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-06 for KETONE STRIP, KETONE 50CT manufactured by Trividia Health Inc.
| Report Number | 1000113657-2019-10129 |
| MDR Report Key | 9285518 |
| Report Source | CONSUMER |
| Date Received | 2019-11-06 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-10-10 |
| Date Facility Aware | 2019-10-10 |
| Date Mfgr Received | 2019-10-10 |
| Date Added to Maude | 2019-11-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN DEVINCENT |
| Manufacturer Street | 2400 NW 55TH COURT |
| Manufacturer City | FORT LAUDERDALE FL 33309 |
| Manufacturer Country | US |
| Manufacturer Postal | 33309 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KETONE |
| Generic Name | SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER |
| Product Code | JIN |
| Date Received | 2019-11-06 |
| Model Number | STRIP, KETONE 50CT |
| Lot Number | AW492 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIVIDIA HEALTH INC |
| Manufacturer Address | 2400 NW 55TH COURT FORT LAUDERDALE FL 33309 US 33309 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-06 |