BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK - MAXON

    MDR report key: 3670400 · Received February 25, 2014

    Report

    Report Number
    1219930-2014-00127
    Event Type
    Death
    Date Received
    February 25, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 29, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GAM
    PMA / PMN Number
    K990951
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC HEMICOLECTOMY ACCORDING TO THE REPORTER: THE SURGEON PERFORMED A LAPAROSCOPIC HEMICOLECTOMY ON (B)(6) 2014 AND THE PT WAS DISCHARGED. ON (B)(6) 2014, THE PT WAS BROUGHT BACK TO THE EMERGENCY ROOM FOR SEPSIS AND FASCIAL DEHISCENCE. MAXON SUTURE WAS USED TO CLOSE THE FASCIA AND IT HAD BROKEN WHERE THE KNOT WAS TIED AFTER THE CASE ON (B)(6) 2014. THE PT WAS RETURNED TO THE OPERATING ROOM FOR A EXPLORATORY LAPAROTOMY AND WAS SUTURED. THE PT EXPIRED EITHER IN PACU OR ICU. THE NURSE MANAGER COULD NOT LOCATE THE MAXON ID OR LOT NUMBERS, BUT THE SURGICAL TECHNOLOGIST SAID THEY USED POLYSORB AND MAXON 3-0 ON THE PROCEDURE, AND THE ONLY THE MAXON BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115637 UNK - MAXON MAXON SUTURE GAM COVIDIEN LP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death