ESOPHAGEAL STETHOSCOPE, 12 FRENCH 81-040412

MAUDE Adverse Event Report

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..

MAUDE Entry Details

Report Number9613793-2019-00004
MDR Report Key9284261
Report SourceDISTRIBUTOR
Date Received2019-11-06
Date of Report2019-11-06
Date of Event2019-10-07
Date Mfgr Received2019-10-14
Date Added to Maude2019-11-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSARAH BENNETT
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653626112
Manufacturer G1DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
Manufacturer StreetGLOBAL PARK BOX 180-3006, 602 PARKWAY
Manufacturer CityLA AURORA, HEREDIA, HEREDIA 146
Manufacturer CountryCS
Manufacturer Postal Code146
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameESOPHAGEAL STETHOSCOPE, 12 FRENCH
Generic NameSTETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS
Product CodeBZT
Date Received2019-11-06
Returned To Mfg2019-10-17
Model Number81-040412
Lot Number49586751
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
Manufacturer AddressGLOBAL PARK BOX 180-3006, 602 PARKWAY LA AURORA, HEREDIA, HEREDIA 146 CS 146


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-06

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