BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 2556782 · Received May 2, 2012

    Report

    Report Number
    1000306051-2012-00024
    Event Type
    Other
    Date Received
    May 2, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 12, 2012
    Manufacturer
    NA
    Product Code
    GXQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO ALLODERM RTU LOT B41211R INCLUDED AS FOLLOWS: REVIEW OF THE DONOR ELIGIBILITY AND RECOVERY RECORDS WITH NO REMARKABLE FINDINGS. REVIEW OF MICROBIOLOGICAL TESTING RESULTS FOR INCOMING SKIN (B)(4) WITH A CONFIRMATION OF NO GROWTH IDENTIFIED IN CULTURE. MICROBIOLOGICAL CULTURES ARE NOT PERFORMED ON THE FINAL PRODUCT AS ALLODERM RTU IS A TERMINALLY STERILIZED PRODUCT. REVIEW OF THE LOT PROCESSING RECORDS FOR ALLODERM RTU LOT (B)(4) WITH NO REMARKABLE FINDINGS. THERE WAS NO NONCONFORMANCES OR DEVIATIONS THAT COULD IMPACT PRODUCT SAFETY. QUERY OF LIFECELL'S COMPLAINT MANAGEMENT SYSTEM REVEALED THAT THERE WERE NO OTHER COMPLAINTS REPORTED TO LIFECELL AGAINST THIS LOT. AS OF (B)(6) 2012, OUT OF THE 14 GRAFTS PRODUCED FOR LOT B41211R, THERE WERE 13 GRAFTS FROM DISTRIBUTED, INCLUDING A 4 GRAFTS THAT WERE REPORTED AS IMPLANTED. THE RETURNED ALLODERM RTU GRAFT WAS SENT FOR PATHOLOGICAL EVALUATION. HISTOLOGICAL FINDINGS SUPPORT GRAFT INFECTION DUE TO (B)(6). THE DISPROPORTIONATE SUPERFICIAL PRESENCE OF ACUTE INFLAMMATORY CELLS AND NECROSIS SUGGESTS SECONDARY INFECTION, BUT CLINICAL CORRELATION IS WARRANTED. THE TISSUE RECOVERY PARTNER WAS QUERIED FOR OTHER COMPLAINTS AGAINST THE DONOR LOT. RESULTS OF THIS QUERY ARE PENDING. LIFECELL IS ATTEMPTING TO OBTAIN MORE INFO FROM THE DOCTOR CONCERNING THIS CASE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN FURTHER INFO IS RECEIVED.

    Description of Event or Problem · 1

    THE PT HAD ALLODERM RTU IMPLANTED ON (B)(6) 2012 DURING BREAST RECONSTRUCTION. IT WAS REPORTED THAT SHE EXPERIENCED RED BREAST, FEVER, UNDERWENT ASPIRATION WHICH WAS (B)(6). THE TISSUE EXPANDER AND ALLODERM RTU WERE REMOVED. THE ALLODERM RTU GRAFT DID NOT INCORPORATE, WHICH IS NOT UNEXPECTED GIVEN A TIME OF LESS THAN 3 WEEKS FROM SURGERY. LIFECELL IS ATTEMPTING TO OBTAIN FURTHER INFO ABOUT THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA NA GXQ NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention