BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE WAX

    MDR report key: 2436815 · Received February 2, 2012

    Report

    Report Number
    2210968-2012-00259
    Event Type
    Injury
    Date Received
    February 2, 2012
    Report Date
    January 9, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    MTJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OPEN SORE. 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 PROCEDURE TO REMOVE BONE SPURS ON (B)(6) 2011 AND BONE WAX WAS USED. THE PATIENT DEVELOPED INFLAMMATION AT THE SITE AND IT DEVELOPED INTO A SORE. THE PATIENT SOAKED HIS HEEL AND CHUNKS OF BONE WAX, LIKE KERNELS OF CORN, CAME OUT. THE PATIENT HAS HAD IN-OFFICE MINOR PROCEDURES. THE WOUND HAS BEEN CLEANED OUT AND PACKED WITH DRESSINGS UNTIL IT CLOSED UP, HOWEVER IT STILL HAS AN ISSUE. THE PATIENT REPORTS THAT HE MAY HAVE TO GO IN FOR ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE WAX SUTURE, NON-ABSORBABLE MTJ ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention