BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CO-FLEX

    MDR report key: 2100916 · Received May 18, 2011

    Report

    Report Number
    MW5020659
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ANDOVER HEALTHCARE, INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD FINGER STUCK FOR BLOOD AND COFLEX BANDAGE WAS APPLIED TO FINGER PUNCTURE SITE. PARENTS AND PT CAME BACK TO HOSPITAL ON (B)(6), 2011, COMPLAINING OF CHILD'S FINGER BEING BLACK AND BLUE. DATES OF USE: (B)(6) 2011, LESS THAN 24 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CO-FLEX LATEX - FREE BANDAGE FRO ANDOVER HEALTHCARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Other