BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT SKIN STAPLER 35W

    MDR report key: 1880803 · Received September 30, 2010

    Report

    Report Number
    3003898360-2010-00427
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Report Date
    September 13, 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

    PRODUCT HAS NOT YET BEEN RECEIVED BY MFR, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: STAPLES WERE NOT FORMING CORRECTLY WHEN THE STAPLER WAS USED FOR CLOSING A SCALP INCISION. NO INJURIES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1