SMARTMIX BOWL 540180000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-08-29 for SMARTMIX BOWL 540180000 manufactured by Depuy Cmw - 9610921.

MAUDE Entry Details

Report Number1818910-2019-102498
MDR Report Key8945197
Report SourceOTHER
Date Received2019-08-29
Date of Report2019-08-08
Date of Event2019-07-22
Date Mfgr Received2019-10-30
Device Manufacturer Date2019-05-01
Date Added to Maude2019-08-29
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 DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY CMW - 9610921
Manufacturer StreetCORNFORD RD
Manufacturer CityBLACKPOOL FY4 4QQ
Manufacturer CountryUK
Manufacturer Postal CodeFY4 4QQ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMARTMIX BOWL
Generic NameBONE CEMENT : CEMENT DELIVERY DEVICES
Product CodeJDZ
Date Received2019-08-29
Returned To Mfg2019-09-24
Catalog Number540180000
Lot Number1903365
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY CMW - 9610921
Manufacturer AddressCORNFORD RD BLACKPOOL FY4 4QQ UK FY4 4QQ


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-29

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