BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT

    MDR report key: 7008740 · Received November 8, 2017

    Report

    Report Number
    2210968-2017-70935
    Event Type
    Injury
    Date Received
    November 8, 2017
    Report Date
    October 11, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE SURGEON BELIEVE THAT ABSORBABLE HEMOSTAT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? CITATION: DIS COLON RECTUM 2010; 53: 889¿895. DOI: 10.1007/DCR.0B013E3181D3206E.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE (REGENERATED OXIDIZED CELLULOSE REINFORCEMENT OF LOW RECTAL ANASTOMOSIS: DO WE STILL NEED DIVERSION?) THAT THE PATIENT UNDERWENT COLORECTAL ANASTOMOSIS ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT POSSIBLY EXPERIENCED ANASTOMOTIC LEAK, PROLONGED ILEUS, ABDOMINAL WOUND DEHISCENCE, AND WOUND INFECTION FROM ANASTOMOTIC LEAK. THE WOUND INFECTION WAS PELVIC ABSCESS, MANAGED BY CT-GUIDED DRAINAGE AND INTRAVENOUS ANTIBIOTICS. THE PATIENT POSSIBLY UNDERWENT PROXIMAL DIVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788083 SURGICEL ABSORBABLE HEMOSTAT HEMOSTATIC AGENT, ABSORBABLE LMF ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1