BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPANDER

    MDR report key: 2801777 · Received October 16, 2012

    Report

    Report Number
    MW5027265
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 21, 2012
    Product Code
    LCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RTI BIOLOGICS, INC. (RTI) HAS INITIATED AN INVESTIGATION BASED ON A COMPLAINT OF POST-OPERATIVE INFECTION REPORTED ON (B)(6) 2012. ON (B)(6) 2012, THE PT UNDERWENT A BILATERAL BREAST RECONSTRUCTION WITH ALLOMAX DERMIS GRAFTS. ON (B)(6) 2012, THE GRAFTS AND EXPANDERS WERE REMOVED. FINAL CULTURES (SIDE UNK) YIELDED PSEUDOMONAS AERUGINOSA. THE PT UNDERWENT ANTIBIOTIC THERAPY FOR 10 DAYS. THE SURGEON REPORTED HE HAS HAD AN INCREASE IN GRAM NEGATIVE INFECTIONS IN SEVERAL PTS POST BREAST RECONSTRUCTION SURGERY. THE SURGEON IS REQUESTING A REVIEW OF RECORDS RELATED TO THE TISSUE. NO COMPLICATIONS WERE REPORTED WITH THE GRAFT IMPLANTED ON THE RIGHT SIDE. BOTH DONOR AND MFG RECORDS ARE RE-REVIEWED AS PART OF RTI'S INVESTIGATION. NO DEVIATIONS WERE NOTED FOR THE DONOR AND ALL RTI DONOR ELIGIBILITY REQUIREMENTS WERE MET. INITIAL REPORTER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPANDER LCJ
    2 EXPANDER LCJ

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other EXP. DATE: 01/31/2017| ALLOMAX DERMIS: LOT 101070670, ID (B)(4),| EXP. DATE: 01/31/2017| ALLOMAX DERMIS: LOT 101078958, ID (B)(4),