BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 4527679 · Received January 22, 2015

    Report

    Report Number
    4527679
    Date Received
    January 22, 2015
    Date of Event
    January 18, 2015
    Report Date
    January 22, 2015
    Manufacturer
    COVIDIEN
    Product Code
    HDJ
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    NURSE WAS ASSESSING BABY AND IDENTIFIED BLEEDING FROM THE BABY'S RIGHT HAND, PINKY FINGER. PRIOR TO NURSE OBSERVING BLEEDING FINGER, NURSE HAD USED CORD CLAMP CUTTER TO REMOVE CORD CLAMP. INFANT'S HANDS WERE NOT NEAR CORD CLAMP CUTTER BLADE WHEN NURSE WAS REMOVING CORD CLAMP. IT IS BELIEVED THAT PINKY MAY HAVE COME IN CONTACT WITH THE HINGE OF THE DEVICE CAUSING THE LACERATION. PRESSURE IMMEDIATELY APPLIED AND PHYSICIAN NOTIFIED. WOUND IRRIGATED AND DRESSED. ORTHOPEDICS CONSULTED AND CLOSED WOUND WITH HISTOACRYL. FINGER REMAINED WARN, PINK, AND NEWBORN WAS ABLE TO MOVE SPONTANEOUSLY. NEWBORN WAS DISCHARGED THE FOLLOWING AFTERNOON AS PLANNED WITH SCHEDULED FOLLOW-UP APPOINTMENT WITH ORTHOPEDIC PHYSICIAN. REASON FOR REPORT PERHAPS A SHIELD ON THE DEVICE OR AN IMPROVEMENT IN THE DESIGN WOULD BE CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51123 * CORD CLAMP CLIPPER HDJ COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY