BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PARKER

    MDR report key: 3012644 · Received February 22, 2013

    Report

    Report Number
    1836161-2013-00101
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO A RECENT FDA INSPECTION THIS MDR IS BEING REPORTED AS A RESULT OF A RE-EVALUATION. INITIAL REPORT, FOLLOW UP WILL BE SENT AFTER EVAL.

    Description of Event or Problem · 1

    DURING 3 SEPARATE CASES, 3 #15 BLADE IS EITHER BREAKING IN HALF OR IN THIRDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78411 BARD PARKER #15 BLADE GES ASPEN SURGICAL PRODUCTS, INC. 0014885, 0021117

    Patients

    Seq Age Sex Outcome Treatment
    1