BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COFLEX NL

    MDR report key: 8731379 · Received June 24, 2019

    Report

    Report Number
    MW5087595
    Event Type
    Injury
    Date Received
    June 24, 2019
    Date of Event
    June 2, 2019
    Report Date
    June 12, 2019
    Manufacturer
    ANDOVER HEALTHCARE INC.
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PARENT PRESENTED (B)(6) PT FOR LAB COLLECTION AT ONE OF OUR CLINICS ON (B)(6) 2019. A CAPILLARY PUNCTURE WAS PERFORMED ON A FINGER. COFLEX NL WAS USED TO BANDAGE THE FINGER. PARENT NOTED SWELLING OF THE FINGER NEAR THE WRAP ON (B)(6) 2019, AND TOOK THE PT TO A LOCAL EMERGENCY ROOM. PT WAS EVALUATED AND A PORTION OF THE FINGER WAS DETERMINED TO BE NECROTIC. THE PT WAS TRANSFERRED TO A HAND SPECIALIST AT CHILDREN'S HOSP WHERE IT WAS DETERMINED A PARTIAL AMPUTATION WAS NEEDED DUE TO RESTRICTED BLOOD FLOW FROM COFLEX BANDAGE. WE HAVE BEEN UNABLE TO FIND CONTRAINDICATIONS FOR COFLEX BANDAGE USE FROM THE MFR OR OUR DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523141 COFLEX NL BANDAGE, ELASTIC FQM ANDOVER HEALTHCARE INC. COFLEX NL

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Other