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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD CP1150 SOUND PROCESSOR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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COCHLEAR LTD CP1150 SOUND PROCESSOR; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number P1320278
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Erythema (1840)
Event Type  Injury  
Event Description
Per the clinic, the patient experienced redness at implant site which eventually turned into a wound.The patient was treated with medication, however, the issue did not resolve.Hardware exchange was attempted and that resolved the issue.
 
Manufacturer Narrative
This report is submitted on august 7, 2023.
 
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Brand Name
CP1150 SOUND PROCESSOR
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 Key17467713
MDR Text Key320471055
Report Number6000034-2023-02563
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P970051
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberP1320278
Was Device Available for Evaluation? No
Date Manufacturer Received07/17/2023
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 Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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