MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-30 for API? ID 32 C 32200 manufactured by Biomerieux, Sa.
Report Number | 9615754-2019-00064 |
MDR Report Key | 8950214 |
Date Received | 2019-08-30 |
Date of Report | 2019-10-16 |
Date Mfgr Received | 2019-10-08 |
Date Added to Maude | 2019-08-30 |
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 | MR. MATTHEW LOCUS |
Manufacturer Street | 595 ANGLUM ROAD |
Manufacturer City | HAZELWOOD MO 63042 |
Manufacturer Country | US |
Manufacturer Postal | 63042 |
Manufacturer G1 | BIOMERIEUX, SA |
Manufacturer Street | 3 ROUTE DE PORT MICHAUD |
Manufacturer City | LA BALME, 38390 |
Manufacturer Country | FR |
Manufacturer Postal Code | 38390 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | API? ID 32 C |
Generic Name | ID 32 C 25STRIPS+25MEDIA |
Product Code | JXB |
Date Received | 2019-08-30 |
Catalog Number | 32200 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BIOMERIEUX, SA |
Manufacturer Address | 3 ROUTE DE PORT MICHAUD LA BALME, 38390 FR 38390 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
0 | 0 | 2019-08-30 | |
1 | 0 | 2019-08-30 |