BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 2720641 · Received August 28, 2012

    Report

    Report Number
    MW5026681
    Event Type
    Other
    Date Received
    August 28, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 21, 2012
    Manufacturer
    *
    Product Code
    LCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    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 WAS 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 MANUFACTURING 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. MUSCULOSKELETAL AND DERMAL TISSUE WERE RECOVERED BY INDEPENDENTLY REGISTERED TISSUE BANKS. RTI AND ITS SUBSIDIARY RECEIVED ALL MUSCULOSKELETAL/DERMAL TISSUE FROM DONORS (B)(6). BOTH DONOR AND MANUFACTURING RECORDS WERE RE-REVIEWED AS PART OF RTI'S INVESTIGATION. NO DEVIATIONS WERE NOTED DURING POST-TUTOPLAST PROCESSING FOR THE DONORS AND ENVIRONMENTAL MONITORING RESULTS WERE ACCEPTABLE DURING AND AROUND THE TIME OF POST TUTOPLAST PROCESSING FOR THE DONORS. REVIEW OF PRE TUTOPLAST PROCESSING AND ENVIRONMENTAL MONITORING ARE PENDING. RTI HAS MANUFACTURED AND DISTRIBUTED A TOTAL OF (B)(4) ALLOGRAFTS FROM DONOR (B)(6) AND RECEIVED (B)(4) RECORDS OF IMPLANTATION WITH (B)(4) RECORDS SPECIFIC TO DERMIS ALLOGRAFTS. (B)(4) HAS MANUFACTURED AND DISTRIBUTED A TOTAL OF (B)(4) ALLOGRAFTS FROM DONOR (B)(6) AND RECEIVED (B)(4) RECORDS OF IMPLANTATION WITH (B)(4) RECORDS SPECIFIC TO DERMIS ALLOGRAFTS. THE GRAFTS WERE MANUFACTURED ACCORDING TO SPECIFICATION. TO DATE, OUR INVESTIGATION IS WITHOUT INDICATION THAT THE GRAFTS CONTRIBUTED TO COMMUNICABLE DISEASE TRANSMISSION. MFR REPORT#: 302719998-2012-025. (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, (B)(6), LOT# 101078958| ALLOMAX DERMIS, (B)(6), LOT# 101070670| EXP DATE: 01/31/2017