BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUBBY TECHNOLOGY HUB

    MDR report key: 15650867 · Received October 21, 2022

    Report

    Report Number
    3020824629-2022-00001
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    July 30, 2022
    Manufacturer
    SENSORY MEDICAL INC
    Product Code
    KMI
    UDI-DI
    00860007550263
    PMA / PMN Number
    510(K)-EXMPT
    Removal / Correction Number
    NO 21 USC 360I(F) ACTION
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NONE FURTHER.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES THAT THE PATIENT CHEWED ON, AND SWALLOWED, "SOME" OF THE TECH HUB RADIO ANTENNA CABLE, AND CHEWED ON AND SWALLOWED SOME OR ALL OF THE CORD FOR THE HUMIDITY / TEMPERATURE SENSOR. THIS HAPPENED AFTER THE PATIENT ACCESSED THE WIRES STOWED INSIDE THE BODY OF THE ASSEMBLED TECH HUB. THIS SEQUENCE OF EVENTS LED TO A HOSPITAL ER VISIT, X-RAYS, SEDATION, NASOGASTRIC TUBE, SURGICAL CONSULTATION, AND MEDICATION. DURING THE ER VISIT, THE PATIENT VOMITED, "WHICH PRODUCED A COUPLE OF THE ELECTRICAL CORDS AND A PLASTIC TAG." THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND DISCHARGED AFTER ONE (1) DAY. PER PATIENT'S CAREGIVER (MOTHER), THERE HAVE BEEN NO COMPLAINTS OF ABDOMINAL PAIN. THE FAMILY MAY HAVE SEEN INDICATION OF THE NATURAL PASSAGE OF A "TINY" WIRE BUT SAID THEY COULDN'T DETERMINE WHETHER FULLER PASSAGE HAS HAPPENED. MOTHER STATES THAT THE FAMILY DOESN'T CURRENTLY HAVE ANY PARTICULAR PLANS FOR ADDITIONAL VISIT(S) TO A PHYSICIAN FOR FURTHER RELATED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647034 CUBBY TECHNOLOGY HUB BED PATIENT MONITOR KMI SENSORY MEDICAL INC KIT10001 NONE 00860007550263

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention| H