MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-06 for AIA-360 019945 manufactured by Tosoh Bioscience, Inc..
| Report Number | 3005529799-2020-00004 |
| MDR Report Key | 9803087 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2017-06-08 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BERNADETTE O'CONNELL |
| Manufacturer Street | 6000 SHORELINE COURT SUITE 101 |
| Manufacturer City | SOUTH SAN FRANCISCO, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 6368143 |
| Manufacturer G1 | TOSOH BIOSCIENCE, INC. |
| Manufacturer Street | 3600 GANTZ ROAD |
| Manufacturer City | GROVE CITY, OH |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIA-360 |
| Generic Name | AIA-360 |
| Product Code | KHO |
| Date Received | 2020-03-06 |
| Model Number | AIA-360 |
| Catalog Number | 019945 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TOSOH BIOSCIENCE, INC. |
| Manufacturer Address | 3600 GANTZ ROAD GROVE CITY, OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |