BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT

    MDR report key: 1790010 · Received August 2, 2010

    Report

    Report Number
    2210968-2010-00898
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 8, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT SURGERY FOR ESOPHAGEAL CANCER ON (B)(6) 2010 AND ABSORBABLE HEMOSTAT WAS USED ON THE WOUND. ON (B)(6) 2010, THE PT COUGHED AND THE FAMILY REPORTED THAT SOMETHING CAME OUT OF THE PT. THE SURGEON CONFIRMED THAT THE EXPELLED MATTER WAS ABSORBABLE HEMOSTAT. THE PT EXPIRED THAT SAME DAY. THE SURGEON CONCLUDED THAT THE "WOUND'S AORTA BROKE AND THE ABSORBABLE HEMOSTAT RUSHED INTO THE ESOPHAGUS, ENTERED THE STOMACH AND WAS THEN COUGHED OUT BY THE PT." ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICEL ABSORBABLE HEMOSTAT HEMOSTATIC AGENT, ABSORBABLE LMF ETHICON, INC. NA 3373687

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention