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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENBREL MINI AUTOINJECTOR; INJECTOR, PEN
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ENBREL MINI AUTOINJECTOR; INJECTOR, PEN Back to Search Results
Health Effect - Clinical Code Insufficient Information (4580)
Type of Reportable Event Serious Injury
Event or Problem Description
Spontaneous call from patient to report the cartridge got stuck in auto injector.Unknown if doses were missed.No side effect reported.Unknown if product on hand for return to manufacturer.No further information provided.Reported to (b)(6) by patient/caregiver.
 
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Brand Name
ENBREL MINI AUTOINJECTOR
Common Device Name
INJECTOR, PEN
MDR Report Key10918763
Report NumberMW5098121
Device Sequence Number1376936
Product Code NSC
Combination Product (Y/N)Y
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) 11/20/2020
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 Date11/25/2020
Patient Sequence Number1
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