BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE WAX

    MDR report key: 2444939 · Received February 9, 2012

    Report

    Report Number
    2210968-2012-00336
    Event Type
    Injury
    Date Received
    February 9, 2012
    Date of Event
    December 20, 2011
    Report Date
    January 20, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    MTJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED AND THEY MET THE REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A COR TRIATRIATUM PROCEDURE ON (B)(6) 2011 AND BONE WAX WAS USED TO STOP BLEEDING ON THE STERNUM. ON ABOUT (B)(6) 2011, 4 TO 6 DAYS AFTER THE PROCEDURE, THE WOUND HAD PENETRATING FLUID ALONG WITH SOME SCRAPS LIKE BONE WAX AND LOCAL INFLAMMATION. THE PATIENT UNDERWENT A SECOND PROCEDURE AND THE WOUND WAS DEBRIDED AND RE-SUTURED. THE PATIENT WAS DISCHARGED AND IS NOW FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE WAX STERILE NONABSORBABLE BONE WAX MTJ ETHICON, INC. NA DC5GTTM

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention