BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 2/0 30 UNDYED HOS-11

    MDR report key: 3143094 · Received May 24, 2013

    Report

    Report Number
    1219930-2013-00405
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    April 28, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: SURGEON STATED THE PT INCISION HAD SOME DEHISCENCE AND WAS SPLITTING AT THE SURGICAL SITE. CURRENT PAINT STATUS: PT IS DOING FINE. DID THE DIFFICULTY RESULT IN UNINTENDED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION ETC-NO. THERE WAS NO UNANTICIPATED TISSUE LOSS. REPORTED: INCREASED SCARING AT THE INCISION SIRE. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH-NO. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT OR COMPONENT FELL INTO THE PTS CAVITY. NO DEVICE FRAGMENT OR COMPONENT WAS LEFT IN THE PT. CORRECT THIS CONDITION-INCISION WAS TREATED AT THE DOCTORS OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232782 POLYSORB 2/0 30 UNDYED HOS-11 POLYSORB GAM COVIDIEN, FORMERLY US SUR A2D0839X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other