BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE WAX

    MDR report key: 2032731 · Received March 17, 2011

    Report

    Report Number
    2210968-2011-00292
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 15, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    MTJ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 03/17/2011. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A REMOVAL OF A BONE SPUR FROM THE RIGHT GREAT TOE IN (B)(6) 2010. ONE MONTH AFTER THE PROCEDURE, THE PT EXPERIENCED REDNESS, SWELLING, CLEAR DRAINAGE AND PAINFUL FOOT. THE PT WAS TREATED WITH COMPRESSION, ANTI-INFLAMMATORIES AND STEROID INJECTIONS WITHOUT IMPROVEMENT. THE PT UNDERWENT SURGICAL INTERVENTION WITH DEBRIDEMENT OF THE BONE WAX.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention