BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL PREMIE ARMBOARD

    MDR report key: 159892 · Received March 27, 1998

    Report

    Report Number
    159892
    Event Type
    Malfunction
    Date Received
    March 27, 1998
    Date of Event
    February 19, 1998
    Report Date
    March 16, 1998
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    BTX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MED RECORD REVIEWED ON 3-16-98. PER REPORT REC'D, SEVERAL SMALL LACERATIONS NOTED ON INFANT'S LEFT ARM, ONE AT INNER ASPECT 1CM ABOVE WRIST AND ANOTHER 2 CM BELOW ANTECUBITAL. THESE LACERATIONS WERE SCABBED OVER. THE LOCATION OF THE LACERATIONS WERE CONSISTENT WITH THE EDGES OF THE ARMBOARD. ARMBOARD WAS PADDED TO PREVENT FURTHER INJURY. NO TREATMENT GIVEN AND LEFT OPEN TO AIR. NEXT DAY NO REDNESS OR DRAINAGE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL PREMIE ARMBOARD ARMBOARD BTX DEROYAL INDUSTRIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DAY Other