MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-06 for ESOPHAGEAL STETHOSCOPE, 12 FRENCH 81-040412 manufactured by Deroyal Cientifica De Latinoamerica S.r.l..
Report Number | 9613793-2019-00004 |
MDR Report Key | 9284261 |
Report Source | DISTRIBUTOR |
Date Received | 2019-11-06 |
Date of Report | 2019-11-06 |
Date of Event | 2019-10-07 |
Date Mfgr Received | 2019-10-14 |
Date Added to Maude | 2019-11-06 |
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 | SARAH BENNETT |
Manufacturer Street | 200 DEBUSK LANE |
Manufacturer City | POWELL TN 37849 |
Manufacturer Country | US |
Manufacturer Postal | 37849 |
Manufacturer Phone | 8653626112 |
Manufacturer G1 | DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
Manufacturer Street | GLOBAL PARK BOX 180-3006, 602 PARKWAY |
Manufacturer City | LA AURORA, HEREDIA, HEREDIA 146 |
Manufacturer Country | CS |
Manufacturer Postal Code | 146 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ESOPHAGEAL STETHOSCOPE, 12 FRENCH |
Generic Name | STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS |
Product Code | BZT |
Date Received | 2019-11-06 |
Returned To Mfg | 2019-10-17 |
Model Number | 81-040412 |
Lot Number | 49586751 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
Manufacturer Address | GLOBAL PARK BOX 180-3006, 602 PARKWAY LA AURORA, HEREDIA, HEREDIA 146 CS 146 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-06 |