BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX

    MDR report key: 5737980 · Received June 21, 2016

    Report

    Report Number
    5737980
    Event Type
    Malfunction
    Date Received
    June 21, 2016
    Date of Event
    May 11, 2016
    Report Date
    May 25, 2016
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    NEW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE STITCH SEPARATED FROM THE NEEDLE WHILE STAFF WAS CLOSING INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392975 STRATAFIX SUTURE, SURGICAL, ABSORBABLE NEW SURGICAL SPECIALTIES MDSO430

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other