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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMGEN REPATHA AUTO-INJ SURECLICK
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AMGEN REPATHA AUTO-INJ SURECLICK Back to Search Results
Health Effect - Clinical Code Cardiac Arrest (1762)
Type of Reportable Event Serious Injury
Event or Problem Description
Patient stated that his heart stopped and he was in the hospital.He is now released.Prescriber aware.Patient will continue on medication.Reported to (b)(6) by: patient/caregiver.Dose or amount: 140 mg; frequency: once every two weeks; route: subcutaneously.Dates of use: from (b)(6) 2016 to current.Diagnosis or reason for use: hyperlipidemia.
 
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Brand Name
REPATHA AUTO-INJ SURECLICK
Common Device Name
REPATHA AUTO-INJ SURECLICK
Manufacturer (Section D)
AMGEN
MDR Report Key8253836
Report NumberMW5083180
Device Sequence Number11134071
Product Code NSC
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/15/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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