UNKNOWN BIOMATERIAL - CEMENT

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 2020-03-13 for UNKNOWN BIOMATERIAL - CEMENT manufactured by Medos International Sàrl Ch.

MAUDE Entry Details

Report Number1526439-2020-00713
MDR Report Key9831135
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-13
Date of Report2020-02-18
Date of Event2017-08-01
Date Mfgr Received2020-02-18
Date Added to Maude2020-03-13
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 StreetCHEMIN-BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal02400
Manufacturer Phone6103142063
Manufacturer G1MEDOS INT SPINE
Manufacturer StreetCHEMIN BLANC 38
Manufacturer CityLE LOCLE
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN BIOMATERIAL - CEMENT
Generic NamePOLYMETHYLMETHACRYLATE BONE CEMENT
Product CodeNDN
Date Received2020-03-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL CH
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-13

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