BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PARKER

    MDR report key: 3012677 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00077
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    June 8, 2012
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A RECENT FDA INSPECTION, THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVALUATION.

    Description of Event or Problem · 1

    THE BLADE SHATTERED INSIDE DONOR ((B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78821 BARD PARKER DISPOSABLE SCALPEL SIZE 20 GES ASPEN SURGICAL PRODUCTS, INC. 0001660

    Patients

    Seq Age Sex Outcome Treatment
    1