BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMAGRAFT

    MDR report key: 1220506 · Received October 16, 2008

    Report

    Report Number
    2028403-2008-00003
    Event Type
    Other
    Date Received
    October 16, 2008
    Date of Event
    August 19, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ADVANCED BIOHEALING, INC
    Product Code
    MGR
    PMA / PMN Number
    P000036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF INFORMATION PROVIDED BY THE TREATING PHYSICIAN AND A REVIEW OF APPLICABLE PRODUCT RECORDS, ADVANCED BIOHEALING'S MEDICAL AFFAIRS EXPERTS CONCLUDED THAT IT IS UNLIKELY THAT THE APPLICATION OF DERMAGRAFT CAUSED THE PATIENT'S INFECTION. ALL LOTS OF DERMAGRAFT MUST PASS EXTENSIVE SAFETY TESTING PRIOR TO BEING RELEASED TO MARKET. INFECTIONS ARE A NORMAL HURDLE IN TREATING DIABETIC FOOT ULCERS AND DERMAGRAFT WAS SHOWN NOT TO INCREASE THE LIKELIHOOD OF THESE EVENTS DURING CLINICAL TRIALS. ADVANCED BIOHEALING, INC. CONSIDERS PATIENT SAFETY ITS NUMBER ONE CONCERN AND IS TRACKING ADVERSE EVENTS TO ENSURE NO TRENDS APPEAR SUGGESTING THAT DERMAGRAFT OR SPECIFIC LOTS OF DERMAGRAFT INCREASE PATIENTS' RISK OF DEVELOPING INFECTIONS. SINCE FEBRUARY OF 2007, ADVANCED BIOHEALING HAS SOLD ALL PIECES OF DERMAGRAFT TO MEDICAL CENTERS AND HAS RECEIVED ONLY 5 REPORTS OF PATIENTS WHO DEVELOPED INFECTIONS WHILE BEING TREATED WITH DERMAGRAFT.

    Description of Event or Problem · 1

    AFTER BEING APPROACHED BY AN ADVANCED BIOHEALING, INC. SALES REPRESENTATIVE IN 2008, DR REPORTED TO ADVANCED BIOHEALING, INC. THAT HIS OFFICE HAD APPLIED DERMAGRAFT TO A PATIENT IN 2008, WHO DEVELOPED A SIGNIFICANT INFECTION WITHIN A WEEK OF APPLICATION. DR. HOLTZMAN WAS CONTACTED TO OBTAIN FURTHER DETAILS. THE PATIENT WAS BEING TREATED FOR DIABETIC ULCERATIONS WITH DERMAGRAFT. THE PATIENT WAS ADMITTED TO MEDICAL CENTER WHERE SHE WAS TREATED BY ANOTHER PHYSICIAN DUE TO A SEPTIC INFECTION OF HER RIGHT FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL SUB MGR ADVANCED BIOHEALING, INC 11045 127621

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention