BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 7101304 · Received December 8, 2017

    Report

    Report Number
    2210968-2017-71691
    Event Type
    Injury
    Date Received
    December 8, 2017
    Report Date
    November 22, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: INTERNATIONAL JOURNAL OF GYNECOLOGICAL PATHOLOGY, OCTOBER 2002; 21(4):422¿423. DOI: 10.1097/01.PGP.0000035814.01856.FD.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE (OXIDIZED CELLULOSE GRANULOMA MIMICKING A PRIMARY OVARIAN TUMOR) THAT THE PATIENT UNDERWENT A HYSTERECTOMY AND RIGHT SALPINGO-OOPHORECTOMY FOR UTERINE BLEEDING AND HEMOPERITONEUM CAUSED BY A RUPTURED CORPUS LUTEUM CYST OF THE RIGHT OVARY. ABSORBABLE HEMOSTAT WAS APPLIED OVER THE PELVIC WALLS AND THE LEFT ADNEXA TO ACHIEVE HEMOSTASIS AND WERE LEFT IN SITU. ONE MONTH LATER, THE PATIENT PRESENTED WITH A TWO-DAY HISTORY OF INTERMITTENT VAGINAL SPOTTING AND LEFT LOWER QUADRANT PAIN. AN ABDOMINAL SONOGRAM REVEALED FLUID IN THE PELVIC CAVITY AND A LEFT OVARIAN MASS. LAPAROTOMY REVEALED HEMOPERITONEUM AND AN ENCAPSULATED, SOFT-TO-FIRM, DARK BROWN, LEFT OVARIAN MASS ASSOCIATED WITH EXTENSIVE PELVIC ADHESIONS. LEFT SALPINGO-OOPHORECTOMY AND LYSIS OF ADHESIONS WERE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880215 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN HEMOSTATIC AGENT, ABSORBABLE LMF ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR