RADIESSE INJECTION NEEDLE * 8044MO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-17 for RADIESSE INJECTION NEEDLE * 8044MO manufactured by Bioform Medical Inc..

Event Text Entries

[16749312] Physician was attempting to inject and medialize the true vocal cords. The injection needle malfunctioned/became clogged and was not useable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2603976
MDR Report Key2603976
Date Received2012-05-17
Date of Report2012-05-17
Date of Event2012-05-17
Report Date2012-05-17
Date Reported to FDA2012-05-17
Date Added to Maude2012-06-07
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 NameRADIESSE INJECTION NEEDLE
Generic NameSYSTEM, VOCAL CORD MEDIALIZATION
Product CodeMIX
Date Received2012-05-17
Model Number*
Catalog Number8044MO
Lot NumberLOG247665
ID Number*
OperatorPHYSICIAN
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerBIOFORM MEDICAL INC.
Manufacturer Address4133 COURTNEY ROAD SUITE 10 FRANKSVILLE WI 53126 US 53126


Patients

Patient NumberTreatmentOutcomeDate
10 2012-05-17

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