BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NABATOFF VEIN STRIPPER SET

    MDR report key: 846047 · Received May 7, 2007

    Report

    Report Number
    2916714-2007-00019
    Event Type
    Injury
    Date Received
    May 7, 2007
    Date of Event
    February 9, 2007
    Report Date
    May 4, 2007
    Manufacturer
    AESCULAP, INC.
    Product Code
    GAI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE USA. THE SAMPLE WAS NOT RETURNED. AN EVALUATION OF ALL AVAILABLE INFORMATION WAS PERFORMED BY THE MANUFACTURER, AESCULAP AG. THE INCIDENT WAS ATTRIBUTED TO POSSIBLE EMBRITTLEMENT OF THE SYNTHETIC MATERIAL AFTER STERILIZATION. PRODUCT WAS MANUFACTURED IN 1998. IN MARCH 2004 A MODIFICATION OF PRODUCT TOOK PLACE.

    Description of Event or Problem · 1

    INCIDENT OCCURRED OUTSIDE THE USA: DURING VEIN STRIPPING PROCEDURE, A PLASTIC PROBE TIP BROKE OFF AND STUCK INSIDE AND REMAINED IN THE PATIENT. REVISION SURGERY WAS PERFORMED TO REMOVE THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NABATOFF VEIN STRIPPER SET STRIPPER, VEIN, REUSABLE GAI AESCULAP, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR