BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENOTROPIN 2-CHAMBER CART

    MDR report key: 12804278 · Received November 10, 2021

    Report

    Report Number
    MW5105282
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    November 4, 2021
    Report Date
    November 5, 2021
    Manufacturer
    PFIZER INC.
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT'S STEP DAD SHARED THAT PEN DEVICE IS JAMMED. THE BUTTON ON THE PEN DEVICE STICKS AND IT DOESN'T TURN TO GIVE DICK SOUND FOR THE DOSE. HE WAS ABLE TO GET THE 2 MG DOSE LAST NIGHT AND THE BUTTON IS HARD TO PUSH. THE PEN DEVICE WAS ABOUT 8 MONTHS OLD. PSR WILL TRANSFER TO ESCALATIONS TO ASSIST WITH MFR REPLACEMENT. UNKNOWN IF PATIENT MISSED A DOSE OR EXPERIENCED AN ADVERSE EVENT. UNKNOWN IF PRODUCT ON HAND FOR RETRIEVAL. THIS PRODUCT COMPLAINT IS REGARDING THE ACTUAL GENOTROPIN PEN DEVICE (I.E. NOT THE CARTRIDGE) WHICH WAS NOT DISPENSED BY (B)(6); LOT/EXP UNKNOWN. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683303 GENOTROPIN 2-CHAMBER CART INJECTOR, PEN NSC PFIZER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male