BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT

    MDR report key: 3061499 · Received April 16, 2013

    Report

    Report Number
    2210968-2013-03974
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 A BENIGN TUMOR REMOVAL PROCEDURE FROM THE RIGHT SUBLAVIAN REGION BEHIND THE PECTORALIS MAJOR ON (B)(6) 2013 AND AN ABSORBABLE HEMOSTAT WAS USED ON THE MUSCLE AND WAS LEFT IN PLACE. ON THE SAME DAY, THE PATIENT EXPERIENCED A POST OPERATIVE REACTION. THE SYMPTOMS WERE PAIN, SWELLING AND ERYTHEMA. THE PATIENT WAS TREATED WITH ANALGESICS AND TRIPLE ANTIBIOTIC THERAPY INTRAVENOUSLY BECAUSE, THE SEVERE INFLAMMATORY REACTION RESEMBLED AN ACUTE INFECTION. THE SURGEON OPINES THAT THE REACTION WAS RELATED TO THE ABSORBABLE HEMOSTAT BECAUSE OF THE TIMING OF THE SYMPTOMS AND THE LACK OF FEVER OR LEUKOCYTOSIS AND ELEVATED EOSINOPHILS. CULTURES OBTAINED WERE ALL NEGATIVE. THE PATIENT'S CONDITION IMPROVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2013. CURRENTLY, THE PATIENT'S STATUS IS IMPROVING. THE PATIENT HAS LESS SWELLING, BUT STILL HAS COMPLAINTS OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163616 SURGICEL ABSORBABLE HEMOSTAT HEMOSTATIC AGENT, ABSORBABLE LMG ETHICON, INC. NA 3670323

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention