BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMACLIP REEUSABLE HANDLE W/DISP. CLIP CART.

    MDR report key: 1082087 · Received July 25, 2008

    Report

    Report Number
    1320894-2008-00099
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Report Date
    July 23, 2008
    Manufacturer
    DESIGN STANDARDS CORP
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE ACTUAL DEVICE, WE WILL RETURN THIS DEVICE TO THE MANUFACTURING SITE FOR AN EVAL. AS SOON AS THE MANUFACTURING ENGINEERS HAVE COMPLETED THEIR INVESTIGATION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE PERMACLIP 1-1082 WAS NEW, AND CLIPS JUMPED. AFTER REPLACEMENT OF THE CARTRIDGE, NORMAL WORKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACLIP REEUSABLE HANDLE W/DISP. CLIP CART. LAP. CLIP APPLIER FZP DESIGN STANDARDS CORP 0710221

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK