BONE WAX 2.5GR W810

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 2019-09-06 for BONE WAX 2.5GR W810 manufactured by Ethicon Inc..

MAUDE Entry Details

Report Number2210968-2019-86684
MDR Report Key8971950
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-09-06
Date of Report2019-08-12
Date of Event2019-08-11
Date Mfgr Received2019-10-18
Device Manufacturer Date2018-04-01
Date Added to Maude2019-09-06
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 ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 088760151
Manufacturer CountryUS
Manufacturer Postal088760151
Manufacturer Phone6107428552
Manufacturer G1ETHICON INC.-AURANGABAD INDIA
Manufacturer Street312379@B-15/1, M.I.D.C. 1 WALU
Manufacturer CityAURANGABAD
Manufacturer CountryIN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBONE WAX 2.5GR
Generic NameWAX, BONE
Product CodeMTJ
Date Received2019-09-06
Returned To Mfg2019-08-30
Catalog NumberW810
Lot NumberB8036
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-09-06

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