BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOGUARD LIMBOARD ARMBOARD

    MDR report key: 237784 · Received August 25, 1999

    Report

    Report Number
    2244861-1999-00001
    Event Type
    Injury
    Date Received
    August 25, 1999
    Date of Event
    August 1, 1999
    Report Date
    August 4, 1999
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    KMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT'S INTERNAL METAL STIFFENER COMPONENT WAS APPARENTLY EXPOSED TO THE PT CAUSING A 1/4" LACERATION ON THE BABIES CHEST AS WELL AS SEVERAL OTHER SCRATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOGUARD LIMBOARD ARMBOARD INTRAVASCULAR CATHETER SECUREMENT DEVICE KMK CAS MEDICAL SYSTEMS, INC. 4400B 042600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention HOSPITAL TAPE PRODUCT INSTEAD. NAME OF THE BRAND| IS UNKNOWN.| FASTENING GEL STRAPS, CHOOSING TO USE SOME SORT OF| THE HOSP PURCHASED THE DEVICE WITHOUT THE