BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W SKIN STAPLER

    MDR report key: 974700 · Received January 7, 2008

    Report

    Report Number
    3003898360-2008-00004
    Event Type
    Malfunction
    Date Received
    January 7, 2008
    Report Date
    December 17, 2007
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICES HAVE NOT BEEN RETURNED FOR EVALUATION. TELEFLEX MEDICAL IS IN THE PROCESS OF EVALUATING UNOPENED SAMPLES. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    TELEFLEX MEDICAL CUSTOMER SERVICE IN OTHER COUNTRY REPORTED AN END-USER ALLEGES THAT THE SKIN STAPLER STAPLES ARE JAMMED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISISTAT 35W SKIN STAPLER SKIN STAPLER GDT TELEFLEX MEDICAL NA T1254313

    Patients

    Seq Age Sex Outcome Treatment
    1