REFOBACIN BONE CEMENT R 1X40G N/A 3003940001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-11-29 for REFOBACIN BONE CEMENT R 1X40G N/A 3003940001 manufactured by Biomet France S.a.r.l..

MAUDE Entry Details

Report Number3006946279-2019-00514
MDR Report Key9391352
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-07
Date Mfgr Received2019-11-11
Device Manufacturer Date2018-07-24
Date Added to Maude2019-11-29
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 ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1BIOMET FRANCE S.A.R.L.
Manufacturer StreetPLATEAU DE LAUTAGNE BP75
Manufacturer CityVALENCE CEDEX 26903
Manufacturer CountryFR
Manufacturer Postal Code26903
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameREFOBACIN BONE CEMENT R 1X40G
Generic NameBONE CEMENT, ANTIBIOTIC
Product CodeMBB
Date Received2019-11-29
Model NumberN/A
Catalog Number3003940001
Lot NumberA750CD0910
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET FRANCE S.A.R.L.
Manufacturer AddressPLATEAU DE LAUTAGNE BP75 VALENCE CEDEX 26903 FR 26903


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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