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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD CP800 SERIES PROCESSING UNIT (SAND); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD CP800 SERIES PROCESSING UNIT (SAND); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number CP800
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Eczema (4547)
Event Date 01/01/2024
Event Type  Injury  
Event Description
Per the clinic, the patient developed an eczema behind the ear with the use of device on (b)(6) 2024.The patient was treated with a combination steroid and antibiotics cream and the issue resolved.
 
Manufacturer Narrative
This report is submitted on march 14, 2024.
 
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Brand Name
CP800 SERIES PROCESSING UNIT (SAND)
Type of Device
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS  2109
Manufacturer (Section G)
COCHLEAR LTD
1 university avenue
macquarie university, nsw 2109
AS   2109
Manufacturer Contact
debbie ang
unit ug-1, vertical podium
no.8 jalan kerinchi
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key18899937
MDR Text Key337617291
Report Number6000034-2024-00495
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberCP800
Was Device Available for Evaluation? No
Date Manufacturer Received02/16/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age25 YR
Patient SexMale
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