MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-19 for AIA-900 022930111 manufactured by Tosoh Corporation.
Report Number | 8031673-2020-00077 |
MDR Report Key | 9855774 |
Report Source | DISTRIBUTOR |
Date Received | 2020-03-19 |
Date of Report | 2020-03-19 |
Date of Event | 2020-02-19 |
Date Mfgr Received | 2020-02-19 |
Device Manufacturer Date | 2010-12-01 |
Date Added to Maude | 2020-03-19 |
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 | MS. BERNADETTE OCONNELL |
Manufacturer Street | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA |
Manufacturer City | MINATO-KU, TOKYO 1058623 |
Manufacturer Country | JA |
Manufacturer Postal | 1058623 |
Manufacturer G1 | TOSOH CORPORATION |
Manufacturer Street | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA |
Manufacturer City | MINATO-KU, 1058623 |
Manufacturer Country | JA |
Manufacturer Postal Code | 1058623 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | AIA-900 |
Generic Name | AIA-900 |
Product Code | KHO |
Date Received | 2020-03-19 |
Model Number | AIA-900 |
Catalog Number | 022930111 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TOSOH CORPORATION |
Manufacturer Address | SHIBA-KOEN FIRST BUILDING 3-8-2 SHIBA MINATO-KU, 1058623 JA 1058623 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-19 |