MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-28 for INVIVODENTAL/TXSTUDIO manufactured by Anatomage Inc..
| Report Number | 3008272529-2019-00016 |
| MDR Report Key | 8942471 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-08-28 |
| Date of Report | 2019-08-26 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2014-03-12 |
| Date Added to Maude | 2019-08-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MEERA KLER |
| Manufacturer Street | 303 ALMADEN BLVD. SUITE 700 |
| Manufacturer City | SAN JOSE CA 95110 |
| Manufacturer Country | US |
| Manufacturer Postal | 95110 |
| Manufacturer G1 | ANATOMAGE INC. |
| Manufacturer Street | 303 ALMADEN BLVD. SUITE 700 |
| Manufacturer City | SAN JOSE CA 95110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95110 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVIVODENTAL/TXSTUDIO |
| Generic Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
| Product Code | LLZ |
| Date Received | 2019-08-28 |
| Lot Number | 5.3 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANATOMAGE INC. |
| Manufacturer Address | 303 ALMADEN BLVD. SUITE 700 SAN JOSE CA 95110 US 95110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-28 |