BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXON 2-0 GS-24 TAPER

    MDR report key: 567926 · Received January 19, 2005

    Report

    Report Number
    MW1034459
    Event Type
    Injury
    Date Received
    January 19, 2005
    Date of Event
    December 29, 2004
    Report Date
    January 19, 2005
    Manufacturer
    USS/DG
    Product Code
    GAN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT BILATERAL BREAST REDUCTION SURGERY. 2-0 MAXON ABSORBABLE SUTURES WERE USED. THE PT WAS RETURNED TO SURGERY WHERE IT WAS DISCOVERED THE PT HAD AN ABSCESS. A SUTURE WAS FOUND IN THE ABSCESS. CLINICAL DIAGNOSIS: RIGHT BREAST SUTURE ABSCESS WITH EXTRUDING SUTURE. THE PT REQUIRED OVERNIGHT HOSPITALIZATION AND IV ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXON 2-0 GS-24 TAPER SUTURE GAN USS/DG MAXON 2-0 6287-51 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R