BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE COMFORT INS SYR 0.5ML 31G 5/16

    MDR report key: 7641110 · Received June 26, 2018

    Report

    Report Number
    MW5078080
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    January 1, 2018
    Report Date
    June 22, 2018
    Manufacturer
    ALLISON MEDICAL, INC.
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S FATHER (B)(6), STATES THAT THE SYR/NEEDLE COMBO THAT WE HAVE SENT WITH THE PATIENT'S SALZEN (THE NEEDLE) HAS "BROKEN 3X IN THE PT'S LEG" PER FATHER'S REQUEST PLS DC ALL NDLS AND SYR FOR THE PT SALZEN DUE RPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479418 SURE COMFORT INS SYR 0.5ML 31G 5/16 SYRINGE, PISTON FMF ALLISON MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR