BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 4-0 VL 30 CV-23

    MDR report key: 3904212 · Received June 2, 2014

    Report

    Report Number
    1219930-2014-00423
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    March 13, 2014
    Report Date
    May 5, 2014
    Manufacturer
    COVIDIEN , FORMERLY US SURGICAL
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: ORTHOPEDIC FOOT SURGERY. ACCORDING TO THE REPORTER: TITAN, A METAL USED TO NAIL BONES, POLYSORB AND DERMALON SUTURE WERE USED IN THE PT. THE PT HAD ALLERGIC REACTION INCLUDING VERY STRONG SWELLING OF THE MUCOSA MEMBRANE. AFTER 4 WEEKS THE DOCTOR NARROWED DOWN THE ALLERGENIC REACTION IS TO THE TITAN OR THE SUTURES. AFTER REMOVING TITAN AND SUTURES THAT PT WAS A BIT BETTER. NEW SUTURES WERE USED AND AFTER 3 DAYS THE NEW SUTURES WERE REMOVED AND THERE WAS PURULENCE. CORTISONE WAS TAKEN IN ADDITION TO THE LORANO. AFTER REMOVING THE SUTURES THE WOUNDS ARE HEALING. SEE ALSO (B)(4) FOR THE DERMALON SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322138 POLYSORB 4-0 VL 30 CV-23 POLYSORB KOG COVIDIEN , FORMERLY US SURGICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other