BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH SURGIDAC 0 48 GRN DLU SU

    MDR report key: 855350 · Received May 23, 2007

    Report

    Report Number
    1219930-2007-00274
    Event Type
    Malfunction
    Date Received
    May 23, 2007
    Date of Event
    May 16, 2007
    Report Date
    May 17, 2007
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT TO FDA ON 05/23/2007.

    Description of Event or Problem · 1

    PROCEDURE: GASTRIC BYPASS. REPORTEDLY, THE NEEDLE BROKE IN HALF AND WAS RETRIEVED FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SURGIDAC 0 48 GRN DLU SU SUTURING DEVICE MFJ NORTH HAVEN - USS A5L412

    Patients

    Seq Age Sex Outcome Treatment
    1 YR