BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION 31 GAUGE

    MDR report key: 2771691 · Received September 30, 2012

    Report

    Report Number
    MW5027123
    Event Type
    Injury
    Date Received
    September 30, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 30, 2012
    Product Code
    FMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PURCHASED RELION SYRINGES FROM (B)(6) AND THE PLUNGER WOULD NOT INJECT INTO MY DOGS SKIN DURING INSULIN SHOT EVEN WHEN USING EXCESSIVE FORCE. RETURNED TO (B)(6) ON (B)(6) AND WAS TOLD NO ONE ELSE BROUGHT THEM BACK FOR REASON I MENTIONED. THEY NEED TO BE TOLD TO TAKE OFF THEIR SHELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION 31 GAUGE SYRINGE FMF

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention