NUCLEUS HYBRID L24 CI24RE (L24) N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-01 for NUCLEUS HYBRID L24 CI24RE (L24) N/A manufactured by Cochlear Ltd.

MAUDE Entry Details

Report Number3005900820-2019-01216
MDR Report Key8751469
Date Received2019-07-01
Date of Report2019-06-10
Date of Event2019-06-07
Date Facility Aware2019-06-10
Report Date2019-07-02
Date Reported to FDA2019-07-02
Date Added to Maude2019-07-01
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNUCLEUS HYBRID L24
Generic NameNUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
Product CodePGQ
Date Received2019-07-01
Returned To Mfg2019-06-24
Model NumberCI24RE (L24)
Catalog NumberN/A
Lot NumberN/A
Device Expiration Date2018-03-06
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Age3 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOCHLEAR LTD
Manufacturer Address1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, 2109 AS 2109


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-01

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