BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECKVISTA ACCESS BALLOON PORT 10MMX70MM

    MDR report key: 6070791 · Received November 1, 2016

    Report

    Report Number
    3003898360-2016-01017
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 27, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K112456
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR WECKVISTA ACCESS BALLOON PORT 10MMX70MM, LOT #73F1600021 INVESTIGATIONS DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IN APPROXIMATELY A TEN DAY PERIOD THE CUSTOMER HAS HAD AT LEAST SIX PORTS THAT BURST DURING USE. THE ADDITIONAL INFORMATION STATED THAT NO PATIENT WAS ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720919 WECKVISTA ACCESS BALLOON PORT 10MMX70MM LAPROSCOPE,GENERAL,PLASTIC SURGERY GCJ TELEFLEX MEDICAL 73F1600021

    Patients

    Seq Age Sex Outcome Treatment
    1