BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEUKOMED SORBACT

    MDR report key: 6449224 · Received March 31, 2017

    Report

    Report Number
    6449224
    Event Type
    Malfunction
    Date Received
    March 31, 2017
    Date of Event
    September 14, 2016
    Report Date
    March 17, 2017
    Manufacturer
    BSN MEDICAL INC.
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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
    231653 LEUKOMED SORBACT DRESSING, WOUND, DRUG FRO BSN MEDICAL INC. 44109305

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR