MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-04 for VIDAS? BRAHAMS PROCALCITONIN 30450-01 manufactured by Biomerieux Sa.
Report Number | 8020790-2019-00031 |
MDR Report Key | 8669246 |
Date Received | 2019-06-04 |
Date of Report | 2019-09-09 |
Date Mfgr Received | 2019-08-14 |
Device Manufacturer Date | 2018-12-05 |
Date Added to Maude | 2019-06-04 |
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. DEBRA BROYLES |
Manufacturer Street | 595 ANGLUM ROAD |
Manufacturer City | HAZELWOOD MO 63042 |
Manufacturer Country | US |
Manufacturer Postal | 63042 |
Manufacturer Phone | 3145068201 |
Manufacturer G1 | BIOMERIEUX SA |
Manufacturer Street | CHEMIN DE L ORME |
Manufacturer City | MARCY L ETOILE, RHONE 69280, |
Manufacturer Country | FR |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | VIDAS? BRAHAMS PROCALCITONIN |
Generic Name | VIDAS? BRAHAMS PCT |
Product Code | PRI |
Date Received | 2019-06-04 |
Catalog Number | 30450-01 |
Lot Number | 1006974220 |
Device Expiration Date | 2019-11-27 |
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 | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280, FR |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-06-04 |