BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 382851 · Received March 15, 2002

    Report

    Report Number
    MW1024414
    Event Type
    Other
    Date Received
    March 15, 2002
    Date of Event
    February 17, 2002
    Report Date
    March 8, 2002
    Manufacturer
    *
    Product Code
    GAO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IS S/P TRANSANAL EXCISION FOR TI RECTAL CANCER IN 2002. TWELVE DAYS LATER, PT AT HOME AND EXPERIENCED PAINLESS RECTAL BLEEDING. PT WENT TO LOCAL HOSP AND WAS ADMITTED. THE NEXT DAY, A FLEXIBLE SIGMOIDOSCOPY WAS PERFORMED AND NO ACTIVE BLEEDING WAS FOUND. THERE WAS AN AREA CONSISTENT WITH AN EXPELLED SUTURE. PT WAS DISCHARGED HOME THE NEXT DAY. INITIAL HOSPITALIZATION WAS 2 DAYS IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SUTURE GAO * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other