HIRES? ULTRA 3D IMPLANT CI-1601-05 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-31 for HIRES? ULTRA 3D IMPLANT CI-1601-05 NA manufactured by Advanced Bionics, Llc.

Event Text Entries

[185892294] Advanced bionics considers the investigation into this reportable event as closed. The recipient's swelling resolved. The recipient resumed device use. This is the final report.
Patient Sequence No: 1, Text Type: N, H10


[185892295] In (b)(6) 2020, the recipient reportedly experienced an infection and swelling over the implant site. The recipient's infection is not device related. The recipient was prescribed 10 days of antibiotics.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006556115-2020-00154
MDR Report Key9908195
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-02
Device Manufacturer Date2019-02-28
Date Added to Maude2020-03-31
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 ContactLACEY MCDONALD
Manufacturer Street28515 WESTINGHOUSE PLACE
Manufacturer CityVALENCIA CA 91355
Manufacturer CountryUS
Manufacturer Postal91355
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHIRES? ULTRA 3D IMPLANT
Generic NameCOCHLEAR IMPLANT
Product CodeMCM
Date Received2020-03-31
Model NumberCI-1601-05
Catalog NumberNA
Lot NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerADVANCED BIONICS, LLC
Manufacturer Address28515 WESTINGHOUSE PLACE VALENCIA CA 91355 US 91355


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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