BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 2/0

    MDR report key: 551633 · Received October 25, 2004

    Report

    Report Number
    1219930-2004-00313
    Event Type
    Injury
    Date Received
    October 25, 2004
    Date of Event
    October 21, 2003
    Report Date
    June 3, 2004
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ANTERIOR/POSTERIOR CERVICAL FUSION. REPORTEDLY, WOUND DEHISCENCE AND INFECTION OCCURRED ON THE SURGICAL SITE. THE PT WAS RETURNED TO SURGERY SEVERAL MONTHS LATER IN 02/2004. IT WAS NOTED THERE WAS A POSSIBLE STAPH INFECTION. THERE IS NO CURRENT PT STATUS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSORB 2/0 BRAIDED, ABSORBABLE, SYNTHETIC, SUTURE GAM UNITED STATES SURGICAL * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R