BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASY POD

    MDR report key: 15174211 · Received August 4, 2022

    Report

    Report Number
    MW5111281
    Event Type
    Injury
    Date Received
    August 4, 2022
    Date of Event
    July 21, 2022
    Report Date
    August 2, 2022
    Manufacturer
    EMD SERONO, INC.
    Product Code
    KZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS TOLD THEY HAD NO MORE DEVICES TO INJECT MY MEDICATION WITH. NO WARNING JUST DIDN'T MAKE ANYMORE. I TAKE THIS MEDICATION FOR LAST 20 YEARS (SAIZEN) FOR MY LIFE AND THEY SAID THEY DIDN'T MAKE ANOTHER DEVICE. THIS IS EMD SERANO THAT THE FDA APPROVED THEIR EASYPOD IN THE US. BUT APPARENTLY THEY LET YOU PAY HUGE AMOUNTS OF MONEY FOR THEIR DRUG BUT DON'T HAVE TO WARN YOU UNTIL YOU CALL FOR A REPLACEMENT DEVICE THAT STOPPED WORKING THEY NO LONGER MAKE THE DEVICE AND HAVE NO REPLACEMENT FOR IT. I WILL DIE WITHOUT THIS MEDICATION BECAUSE I CANT MAKE GROWTH HORMONE IN MY BODY. I DONT HAVE THE TEST BECAUSE DR DIED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433836 EASY POD INJECTOR, FLUID, NON-ELECTRICALLY POWERED KZE EMD SERONO, INC. SW -REV R 4 5

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Life Threatening ALPHALIPOIC ACID | ARMOUR THYROID 60 MG- 2 | B12| B6| GLUCOSAMINE CHONDROTIN| MELATONIN 0.25 MG| SAIZEN 8.8 MG SAIZEN PREP- 3 | SPIRONOLACTONE 50 MG-1 | TUMERIC | VIT C| ZINC