FDA.reportPublic FDA data

MAUDE MDR 9758021

MDR report key
9758021
Report number
1045834-2020-00345
Event key
0
Event type
3
Date of event
2020-01-01
Date received
2020-02-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KARA DITTY-BOVARD
Address
4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US
Phone
610-610-6103
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BLACKMAX-NEURO LOW PRESSUREMOTOR, DRILL, PNEUMATIC - HANDPIECEDEPUY SYNTHES PRODUCTS LLCHBBBLACKMAX-N-LPR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-260

Event Narratives#

No narrative records found.