BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLEY NEONATE SCISSORS

    MDR report key: 1061688 · Received June 12, 2008

    Report

    Report Number
    1061688
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 12, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING LEFT INGUINAL HERNIA REPAIR. COOLEY SCISSORS BROKE IN HALF AND THEN ONE SIDE BROKE IN HALF AGAIN, ALL DURING OR CASE. SCREW FROM SCISSORS DID NOT ENTER THE PATIENT WOUND. FOUND ON PATIENT'S ABDOMEN. ALL PIECES OF SCISSORS ACCOUNTED FOR. PATIENT DISCHARGED TO HOME WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLEY NEONATE SCISSORS SCISSORS LRW CARDINAL HEALTH CH6950-008 *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR NO OTHER THERAPIES| NO OTHER THERAPIES