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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENBREL SURECLICK PF AUTOINJECTOR; INJECTOR, PEN
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ENBREL SURECLICK PF AUTOINJECTOR; INJECTOR, PEN Back to Search Results
Lot Number 1134697
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/28/2021
Type of Reportable Event Malfunction
Event or Problem Description
Spontaneous call from patient reported product complaint for enbrel.Device malfunctioned (b)(6) 2021 the needle did not come out of the pen and bubbles appeared.No dose was administered.No additional information to provide at this time.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
ENBREL SURECLICK PF AUTOINJECTOR
Common Device Name
INJECTOR, PEN
MDR Report Key12737963
Report NumberMW5105067
Device Sequence Number19593914
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) 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date04/01/2024
Device Lot Number1134697
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/01/2021
Was Device Evaluated by Manufacturer? (Y/N) No Information
Usage of Device N
Patient Sequence Number1
Patient Age61 YR
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