BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISISTAT 35W 6/BOX

    MDR report key: 3123708 · Received May 14, 2013

    Report

    Report Number
    3003898360-2013-00199
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RECEIVED BY MANUFACTURER. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ANY ISSUES RELATED TO THIS COMPLAINT. COMPLAINT NOT CONFIRMED. A ROOT CAUSE CAN NOT BE DETERMINED SINCE THE SAMPLE WAS NOT AVAILABLE. MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: STAPLES DO NOT CLOSE PROPERLY DURING USE. ONE SIDE OF THE STAPLES KEEPS OPENING. NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212972 VISISTAT 35W 6/BOX STAPLES GDT TELEFLEX MEDICAL 01G1200356

    Patients

    Seq Age Sex Outcome Treatment
    1