BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE

    MDR report key: 7411625 · Received April 9, 2018

    Report

    Report Number
    MW5076399
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 28, 2018
    Report Date
    April 6, 2018
    Manufacturer
    UNK
    Product Code
    MQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF MANY NEEDLES NOT WORKING. NO MATTER HOW HARD HE PRESSES ON THE BUTTON TO RELEASE THE DOSE, INSULIN DOES NOT COME THROUGH THE NEEDLE. VERIFIED WITH PATIENTS THAT BOTH CAPS WERE REMOVED AND NEEDLE WAS ATTACHED TO PEN PROPERLY. PATIENT STATED THAT SOME NEEDLES IN THE BOX WORKED, WHILE OTHERS DID NOT. SYMPTOMS: DEFECTIVE NEEDLE. SUSPECT DRUG: #1 DOSING: USE TO INJECT INSULIN 4 TIMES PER DAY. DIAGNOSIS FOR USE: DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248791 NEEDLE NEEDLE MQX UNK 458512P

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other