MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-20 for VITEK? 2 AST-GP67 TEST KIT 22226 manufactured by Biomerieux, Inc..
Report Number | 1950204-2020-00083 |
MDR Report Key | 9861135 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2020-03-20 |
Date of Report | 2020-03-20 |
Date Mfgr Received | 2020-02-21 |
Device Manufacturer Date | 2019-10-18 |
Date Added to Maude | 2020-03-20 |
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 | MRS. DANIELLE COOPER |
Manufacturer Street | 595 ANGLUM ROAD |
Manufacturer City | HAZELWOOD MO 63042 |
Manufacturer Country | US |
Manufacturer Postal | 63042 |
Manufacturer G1 | BIOMERIEUX, INC. |
Manufacturer Street | 595 ANGLUM ROAD |
Manufacturer City | HAZELWOOD MO 63042 |
Manufacturer Country | US |
Manufacturer Postal Code | 63042 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | VITEK? 2 AST-GP67 TEST KIT |
Generic Name | VITEK? 2 AST-GP67 TEST KIT |
Product Code | LON |
Date Received | 2020-03-20 |
Catalog Number | 22226 |
Lot Number | 1321239413 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BIOMERIEUX, INC. |
Manufacturer Address | 595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-20 |