BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVSUB412-G27 12MM- SUBQ SET

    MDR report key: 2700700 · Received August 9, 2012

    Report

    Report Number
    MW5026495
    Event Type
    Injury
    Date Received
    August 9, 2012
    Date of Event
    August 3, 2012
    Report Date
    August 9, 2012
    Manufacturer
    EVANS MEDICAL
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ONE OF THE SUBQ INJECTION NEEDLE WAS VERY DULL AND PAINFUL TO USE SUB 412 G27, 12MM, LOT # 1203079. DATE OF USE: (B)(6) 2012. REASON FOR USE: HYPOGAMMAGLOBULINEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVSUB412-G27 12MM- SUBQ SET SUBCUTANEOUS NEEDLE SET FOZ EVANS MEDICAL EVSUB412-G27 12MM 1203079

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HIZENTRA 20%| SUBQ SET WAS USED WHEN PT ADMINISTERED