BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURE COMEFORT INSULIN SYRINGES

    MDR report key: 2442432 · Received February 3, 2012

    Report

    Report Number
    MW5024148
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    January 2, 2012
    Report Date
    February 3, 2012
    Manufacturer
    ALLISON MEDICAL INC
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SURECOMFORT SYRINGES DULL AND POTENTIALLY DANGEROUS. DATES OF USE: (B)(6) 2010 - (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURE COMEFORT INSULIN SYRINGES INSULIN SYRINGES U 100 FMF ALLISON MEDICAL INC 1/2CC 50 UNIT OF LESS 1020

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability