BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CO-FLEX

    MDR report key: 5731900 · Received June 17, 2016

    Report

    Report Number
    5731900
    Event Type
    Injury
    Date Received
    June 17, 2016
    Date of Event
    May 8, 2016
    Report Date
    June 13, 2016
    Manufacturer
    ANDOVER HEALTHCARE INC.
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    YOUNG FEMALE, STATUS POST (S/P) LIVER TRANSPLANT HAD A BANDAGE PLACED ON FINGER AND IT WAS NOT REMOVED UNTIL 48 HOURS LATER; THE FINGER APPEARS NECROTIC WITH POSSIBILITY OF LOSING TIP OF FINGER. PATIENT HAD FINGER STICK FOR BLOOD WORK, ACE BANDAGE APPLIED SECONDARY TO INABILITY TO STOP BLEEDING, ADMITTED, AND BANDAGE REMOVED 48 HOURS LATER ON THE UNIT. NECROTIC AREA NOTED UPON ACE BANDAGE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387745 CO-FLEX BANDAGE, ELASTIC FQM ANDOVER HEALTHCARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR