BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH SURGIDAC DLU

    MDR report key: 1048922 · Received May 21, 2008

    Report

    Report Number
    1219930-2008-00400
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    MFJ
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT SENT: 05/21/2008.

    Description of Event or Problem · 1

    PROCEDURE TYPE: HERNIA REPAIR. ACCORDING TO THE REPORTER: SUTURE BROKE OFF AT THE NEEDLES. THE DOCTOR CHANGED HIS TECHNIQUES AND USED AN ADD'L LOAD TO GET THE JOB DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO STITCH SURGIDAC DLU NON-ABSORBABLE SUTURE LOADING UNIT MFJ NORTH HAVEN - USS A8C603

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK