NUCLEUS HYBRID L24 CI24RE (L24) NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-23 for NUCLEUS HYBRID L24 CI24RE (L24) NA manufactured by Cochlear Ltd.

Event Text Entries

[97943137] This report is submitted january 23, 2018.
Patient Sequence No: 1, Text Type: N, H10


[97943138] It was reported that the patient experienced necrosis at the implant site in (b)(6) 2017 and subsequently was treated with a topical steroid (duration not reported).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2018-00191
MDR Report Key7211563
Report SourceHEALTH PROFESSIONAL
Date Received2018-01-23
Date of Report2018-01-12
Date Mfgr Received2018-01-12
Device Manufacturer Date2011-03-08
Date Added to Maude2018-01-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationAUDIOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. SUJEEWA WIJESINGHE
Manufacturer Street1 UNIVERSITY AVENUE
Manufacturer CityMACQUARIE UNIVERSITY, NSW 2109
Manufacturer CountryAS
Manufacturer Postal2109
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNUCLEUS HYBRID L24
Generic NameNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Product CodePGQ
Date Received2018-01-23
Model NumberCI24RE (L24)
Catalog NumberNA
Lot NumberNA
Device Expiration Date2013-03-07
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOCHLEAR LTD
Manufacturer Address1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109 AS 2109


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-01-23

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