RHOTON MICRE CURETTE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-11 for RHOTON MICRE CURETTE * manufactured by Carefusion Division Of V.mueller.

Event Text Entries

[21283354] During a cervical disk surgery, rhoton dissector (microcurette) broke off but the fragment was located by the neurosurgeon and removed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2028695
MDR Report Key2028695
Date Received2011-03-11
Date of Report2011-03-11
Date of Event2011-02-21
Report Date2011-03-11
Date Reported to FDA2011-03-11
Date Added to Maude2011-03-24
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameRHOTON MICRE CURETTE
Generic NameMICROCURETTE, ANGLED
Product CodeGDI
Date Received2011-03-11
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Age1 YR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION DIVISION OF V.MUELLER
Manufacturer Address5 SUNNEN DR. SAINT LOUIS MO 63143 US 63143


Patients

Patient NumberTreatmentOutcomeDate
10 2011-03-11

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