MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-06 for KETO-MOJO TD-4279 manufactured by Taidoc Technology Corporation.
| Report Number | 3004145393-2019-00001 |
| MDR Report Key | 8863223 |
| Date Received | 2019-08-06 |
| Date of Report | 2018-12-12 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2019-08-06 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ANNE KUO |
| Manufacturer Street | B1-7F, NO.127, WUGONG 2ND RD. WUGU DIST. |
| Manufacturer City | NEW TAIPEI CITY, 24888 |
| Manufacturer Country | TW |
| Manufacturer Postal | 24888 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KETO-MOJO |
| Generic Name | B-KETONE & BLOOD GLUCOSE MONITORING SYSTEM |
| Product Code | JIN |
| Date Received | 2019-08-06 |
| Model Number | TD-4279 |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAIDOC TECHNOLOGY CORPORATION |
| Manufacturer Address | B1-7F, NO. 127, WUGONG 2ND RD. WUGU DIST. NEW TAIPEI CITY, 24888 TW 24888 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-06 |