HUMERAL IMPLANT DRIVER 2307-83-000 230783000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-03 for HUMERAL IMPLANT DRIVER 2307-83-000 230783000 manufactured by Depuy France Sas - 3003895575.

MAUDE Entry Details

Report Number1818910-2020-06690
MDR Report Key9780478
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-03
Date of Report2020-02-13
Date of Event2020-02-13
Date Mfgr Received2020-02-13
Device Manufacturer Date2015-01-16
Date Added to Maude2020-03-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUMERAL IMPLANT DRIVER
Generic NameEXTREMITY INSTRUMENTS : HANDLES
Product CodeHWR
Date Received2020-03-03
Returned To Mfg2020-02-25
Model Number2307-83-000
Catalog Number230783000
Lot Number5240067
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY FRANCE SAS - 3003895575
Manufacturer Address7 ALLEE IRENE JOLIOT-CURIE B.P. 256 SAINT PRIEST CEDEX 69801 FR 69801


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-03

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