STANDARD CRANIOTOME, BLACK MAX B-GREEN

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 2019-06-11 for STANDARD CRANIOTOME, BLACK MAX B-GREEN manufactured by Depuy Synthes Products Llc.

MAUDE Entry Details

Report Number1045834-2019-53799
MDR Report Key8686976
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-06-11
Date of Report2019-04-09
Date Mfgr Received2019-05-29
Device Manufacturer Date2015-04-20
Date Added to Maude2019-06-11
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. KARA DITTY-BOVARD
Manufacturer Street4500 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal33410
Manufacturer Phone6103142063
Manufacturer G1DEPUY SYNTHES PRODUCTS LLC
Manufacturer Street4500 RIVERSIDE DRIVE
Manufacturer CityPALM BEACH GARDENS FL 33410
Manufacturer CountryUS
Manufacturer Postal Code33410
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTANDARD CRANIOTOME, BLACK MAX
Generic NameBUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME
Product CodeGFF
Date Received2019-06-11
Returned To Mfg2019-04-25
Catalog NumberB-GREEN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDEPUY SYNTHES PRODUCTS LLC
Manufacturer Address4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-11

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