PROSTHESIS - FLEX HA 0550

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 2019-08-14 for PROSTHESIS - FLEX HA 0550 manufactured by Medtronic Xomed Inc..

MAUDE Entry Details

Report Number1045254-2019-00383
MDR Report Key8893069
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-08-14
Date of Report2019-08-14
Date of Event2019-07-16
Date Mfgr Received2019-07-22
Device Manufacturer Date2017-06-27
Date Added to Maude2019-08-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCHRISTY CAIN
Manufacturer Street6743 SOUTHPOINT DRIVE NORTH
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal32216
Manufacturer Phone9043328353
Manufacturer G1MEDTRONIC XOMED INC.
Manufacturer Street6743 SOUTHPOINT DR N
Manufacturer CityJACKSONVILLE FL 32216
Manufacturer CountryUS
Manufacturer Postal Code32216
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROSTHESIS - FLEX HA
Generic NameREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
Product CodeETA
Date Received2019-08-14
Model Number0550
Catalog Number0550
Lot Number0213544652
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC XOMED INC.
Manufacturer Address6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.