BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTRIDGE

    MDR report key: 7002947 · Received November 6, 2017

    Report

    Report Number
    MW5073151
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 28, 2017
    Report Date
    October 31, 2017
    Manufacturer
    UNK
    Product Code
    EJI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT STATED THAT CARTRIDGE MALFUNCTIONED AND PT WAS NOT ABLE TO GIVE DOSAGE. PRESCRIBER AND MFR ARE AWARE. PT WILL CONTINUE ON MEDICATION. DOSE OR AMOUNT: 100MCG, FREQUENCY: DAILY, ROUTE: SUBCUTANEOUSLY. DATES OF USE: FROM (B)(6) 2016 TO ONGOING. DIAGNOSIS OR REASON FOR USE: HYPOPARATHYROIDISM. REPORTED TO (B)(6) BY: PT/CAREGIVER. PHYSICIAN NAME: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784001 CARTRIDGE SYRINGE, CARTRIDGE EJI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR