METAGLENE HOLDER 2307-87-005 230787005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for METAGLENE HOLDER 2307-87-005 230787005 manufactured by Depuy France Sas - 3003895575.

MAUDE Entry Details

Report Number1818910-2020-08760
MDR Report Key9860763
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-20
Date of Report2020-03-02
Date Mfgr Received2020-03-23
Device Manufacturer Date2017-12-15
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
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 NameMETAGLENE HOLDER
Generic NameEXTREMITY INSTRUMENTS : HANDLES
Product CodeHWA
Date Received2020-03-20
Returned To Mfg2020-03-23
Model Number2307-87-005
Catalog Number230787005
Lot Number5306514
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
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 2020-03-20

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