BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT

    MDR report key: 4213216 · Received September 30, 2014

    Report

    Report Number
    1836161-2014-00055
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE EYE OF 2 NEEDLES BROKE. CUSTOMER DOES NOT HAVE SAMPLES OF THE BROKEN NEEDLE, BUT WILL SEND BACK PRODUCT FROM THE SAME LOT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609634 NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT NEEDLE 1/2 CIRCLE TAPER POINT MAYO CATGUT FMI ASPEN SURGICAL PRODUCTS, INC 216701 51761

    Patients

    Seq Age Sex Outcome Treatment
    1