BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORTH COAST MEDICAL INC

    MDR report key: 305057 · Received November 15, 2000

    Report

    Report Number
    MW1020437
    Event Type
    Malfunction
    Date Received
    November 15, 2000
    Date of Event
    November 12, 2000
    Report Date
    November 14, 2000
    Manufacturer
    NORTH COAST MEDICAL INC.
    Product Code
    FYH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT FOUND IN BED CHEWING AT EDGE OF SOFT SPLINT LOCATED ON RIGHT ARM. SPLINT HAD SLID DOWN TO RESIDENT'S FINGERS. RESIDENT CHEWING, BROKE ZIPPER OPEN. RESIDENT WAS COVERED WITH STYROFOAM BEADS APPROX 1/2 CM IN SIZE. RESIDENT HAD THESE BEADS IN HER MOUTH, EARS, EYES, HAIR AND CLOTHING. BEADS WERE REMOVED FROM MOUTH, EARS, EYES, HAIR AND CLOTHING. UPON EAR EXAM ONE BEAD WAS INSIDE EAR CANAL. PHYSICIAN CAME 11/13 AND REMOVED BEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORTH COAST MEDICAL INC SOFT SPLINT XX-LARGE FYH NORTH COAST MEDICAL INC. NC 19300-6 *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other