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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTERNAL DIGITAL COCHLEAR IMPLANT

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INTERNAL DIGITAL COCHLEAR IMPLANT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Emotional Changes (1831); Headache (1880); Pain (1994); Respiratory Distress (2045); Swelling (2091)
Event Date 02/10/2018
Event Type  Injury  
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Brand NameINTERNAL DIGITAL COCHLEAR IMPLANT
Type of DeviceINTERNAL DIGITAL COCHLEAR IMPLANT
MDR Report Key7269608
Report NumberMW5075230
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 02/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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