BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT

    MDR report key: 2860849 · Received December 6, 2012

    Report

    Report Number
    2210968-2012-07944
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: ONE UNOPENED REPRESENTATIVE SAMPLE WAS VISUALLY EXAMINED. THE FOIL POUCH REVEALED THAT THERE WAS A TEAR ON THE UPPER RIGHT CORNER OF THE POUCH AND ANOTHER TEAR IN THE BOTTOM LEFT CORNER OF THE POUCH. THE TEARS SEEM TO BE RELATED TO AN ATTEMPT TO OPEN THE FOIL POUCH OR PRODUCT HANDLING SUBSEQUENT TO THE MANUFACTURING OF THE PRODUCT. THE CONDITION OF THE FOIL POUCH USED ON THE OPERATION IS NOT KNOWN. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE ABSORBABLE HEMOSTAT WAS USED TO STOP BLEEDING AT THE HEPATIC PARENCHYMA OF THE RESECTION SURFACE. THE WOUND WAS CLOSED WITH THE ABSORBABLE HEMOSTAT LEFT IN PLACE. THE YELLOW CLOUDY, CONTAMINATED/INFECTED BILE WAS CULTURED AND PROTEUS PNEUMONIA WAS FOUND. THE PATIENT WAS GIVEN ANTIBIOTICS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 PATIENT UNDERWENT A RESECTION OF A SMALL HEPATOCELLULAR CARCINOMA ON (B)(6) 2012 AND AN ABSORBABLE HEMOSTATIC AGENT WAS USED. AFTER THE FIRST POST OPERATIVE DAY THE PATIENT DEVELOPED A FEVER AND YELLOW DRAINAGE. THE SURGEON DRAINED THE FLUID THROUGH DRAINAGE TUBE. THE PATIENT IS NOW IN GOOD CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICEL ABSORBABLE HEMOSTAT HEMOSTATIC AGENT, ABSORBABLE LMG ETHICON, INC. NA EDB175-1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention