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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD COCHLEAR NUCLEUS CP1000 ACCESSORIES NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD COCHLEAR NUCLEUS CP1000 ACCESSORIES NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CP1000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is filed on december 22, 2017.

 
Event Description

Per the clinic, the patient experienced an infection behind the ear with use of the external sound processor. Clinical management is ongoing.

 
Manufacturer Narrative

It was reported the patient was treated with oral antibiotics and a topical steroid (date and duration not reported). The symptoms had reportedly improved.

 
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Brand NameCOCHLEAR NUCLEUS CP1000 ACCESSORIES
Type of DeviceNUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS 2109
Manufacturer Contact
sujeewa wijesinghe
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7140973
MDR Text Key95580951
Report Number6000034-2017-02381
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberP970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial,Followup
Report Date 12/26/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCP1000
Device Catalogue NumberZ544854
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/21/2017 Patient Sequence Number: 1
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