BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER 35 W

    MDR report key: 1812389 · Received June 23, 2010

    Report

    Report Number
    3003898360-2010-00262
    Event Type
    Malfunction
    Date Received
    June 23, 2010
    Report Date
    June 1, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: OTHER - DHR REVIEW PERFORMED. SAMPLE RETURNED TO MANUFACTURER, BUT INVESTIGATION WAS NOT COMPLETE AT TIME OF THIS REPORT. RESULTS: OTHER - DHR REVIEW SHOWED NO ISSUES WITH THIS LOT #. CONCLUSION: OTHER - (B)(4) WAS ISSUED THAT ADDRESSES THE ISSUE OF STAPLES NOT FORMING.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: STAPLES WERE NOT FORMED CORRECTLY. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT SKIN STAPLER 35 W SKIN STAPLER GDT TELEFLEX MEDICAL NA 01G0900215

    Patients

    Seq Age Sex Outcome Treatment
    1