BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RICHARD ALLEN 1/2 TAPER REGULAR

    MDR report key: 1032292 · Received April 21, 2008

    Report

    Report Number
    1836161-2008-00002
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 7, 2008
    Report Date
    April 6, 2008
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GAB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO ASPEN FOR EVALUATION.

    Description of Event or Problem · 1

    DURING THE PROCESS OF SEWING UP THE PATIENT, THE EYED PORTION OF THE NEEDLE BROKE. ALL OF THE NEEDLE WAS FOUND AND RETRIEVED WITHOUT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARD ALLEN 1/2 TAPER REGULAR NEEDLE, SURGICAL, EYED GAB ASPEN SURGICAL PRODUCTS, INC. 209503 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1