MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-12-11 for CHROMID? SALMONELLA AGAR 43621 manufactured by Biomerieux S.a..
Report Number | 9615755-2019-00020 |
MDR Report Key | 9452061 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
Date Received | 2019-12-11 |
Date of Report | 2020-03-11 |
Date Mfgr Received | 2020-02-13 |
Device Manufacturer Date | 2019-05-29 |
Date Added to Maude | 2019-12-11 |
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. CANDACE MARTIN |
Manufacturer Street | 595 ANGLUM ROAD |
Manufacturer City | HAZELWOOD MO 63042 |
Manufacturer Country | US |
Manufacturer Postal | 63042 |
Manufacturer G1 | BIOMERIEUX S.A. |
Manufacturer Street | 5 RUE DES AQUEDUCS |
Manufacturer City | CRAPONNE, 69290 |
Manufacturer Country | FR |
Manufacturer Postal Code | 69290 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CHROMID? SALMONELLA AGAR |
Generic Name | CHROMID? SALMONELLA AGAR |
Product Code | JSI |
Date Received | 2019-12-11 |
Catalog Number | 43621 |
Lot Number | 1007376340 |
Device Expiration Date | 2019-10-16 |
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 S.A. |
Manufacturer Address | 5 RUE DES AQUEDUCS CRAPONNE, 69290 FR 69290 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-12-11 |