BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEUKOMED SORBACT

    MDR report key: 7351851 · Received March 20, 2018

    Report

    Report Number
    8043991-2017-00002
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    September 14, 2016
    Report Date
    September 20, 2017
    Manufacturer
    ABIGO MEDICAL AB
    Product Code
    FRO
    PMA / PMN Number
    K063059
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VERY LIMITED INFORMATION IS AVAILABLE FOR THIS REPORT.

    Description of Event or Problem · 1

    AFTER THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT, A LEUKOMED SORBACT DRESSING WAS PLACED ON HER SURGICAL SITE. AFTER AN UNEVENTFUL ADMISSION, SHE WAS DISCHARGED TWO DAYS LATER. ABOUT A MONTH LATER, THE PATIENT WAS SENT TO THE ED BY HER SURGEON DUE TO THE DEVELOPMENT OF A CHEMICAL BURN WITH ESCHAR ON THE ENTIRE SURGICAL SITE. THE PATIENT UNDERWENT SURGERY TO REMOVE THE ESCHAR. SHE WAS DISCHARGED HOME TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196981 LEUKOMED SORBACT LEUKOMED SORBACT FRO ABIGO MEDICAL AB 10X25CM 44109305

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other