BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG

    MDR report key: 1728638 · Received June 4, 2010

    Report

    Report Number
    2917293-2010-00007
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Report Date
    May 10, 2010
    Manufacturer
    GENENTECH, INC.
    Product Code
    KZE
    PMA / PMN Number
    20-522
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EXPERIENCED INJECTION SITE PAIN [INJECTION SITE PAIN]. CASE DESCRIPTION: THIS SPONTANEOUS CASE WAS RECEIVED FROM A PHARMACIST AND CONCERNED A MALE CHILD OF UNREPORTED AGE. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNKNOWN DATE THE PATIENT STARTED TREATMENT WITH NUTROPIN AQ (SOMATROPIN), FOR AN UNKNOWN INDICATION. THE DOSE, FREQUENCY AND BATCH NUMBER WERE NOT REPORTED. ON AN UNKNOWN DATE THE PATIENT EXPERIENCED PAIN, BLEEDING AND MINOR BRUISING, ALL OCCURRING AT THE INJECTION SITE. ACTION TAKEN WITH NUTROPIN AQ WAS NOT REPORTED. THE OUTCOME OF THE EVENT WAS NOT REPORTED. THE REPORTER STATED THAT THE EVENTS WERE CAUSED BY THE NUTROPIN PEN AS IT TOOK 2-3 ATTEMPTS TO PRESS THE DOSE KNOB IN ORDER TO ADMINISTER THE MEDICATION. CASE CORRECTION PERFORMED ON (B)(4)-2010: LABELLING FOR 'FAULT WITH NUTROPIN PEN' ADDED AS UNLISTED. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUTROPIN AQ PEN (SOMATROPIN) SOLUTION FOR INJECTION 10MG NONE KZE GENENTECH, INC. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1