BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT

    MDR report key: 3003754 · Received March 14, 2013

    Report

    Report Number
    2210968-2013-02400
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 17, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INABILITY TO ACHIEVE HEMOSTASIS. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT TREATMENT FOR A BLEEDING LIP ON (B)(6) 2013 AND AN ABSORBABLE HEMOSTATIC AGENT WAS USED ON THE LIP. THE DEVICE WAS LEFT IN PLACE FOR 30 MINUTES. WHEN THE DEVICE WAS REMOVED THE LIP WAS STILL BLEEDING. SILVER NITRATE WAS APPLIED AND THE BLEEDING SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107382 SURGICEL ABSORBABLE HEMOSTAT HEMOSTATIC AGENT, ABSORBABLE LMG ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention