BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PARKER

    MDR report key: 3040392 · Received March 12, 2013

    Report

    Report Number
    1836161-2013-00105
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER INDICATED THAT THE "BLADE BROKE JUST AS THEY WERE ABOUT TO USE IT." NOTES: BLADE WAS TO BE USED IN THE WOUND CARE CLINIC. THE BLADE BROKE IN THE FRONTAL DISTAL END. NOT CONTAMINATED - NOT USED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104258 BARD PARKER #15 SCALPEL GES ASPEN SURGICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1