BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAZY BOY RECLINER - MEDICAL GRAD

    MDR report key: 8078548 · Received November 15, 2018

    Report

    Report Number
    MW5081376
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 28, 2018
    Report Date
    November 13, 2018
    Manufacturer
    KNU, LLC
    Product Code
    KMN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE ADMITTED WITH DIVERTICULITIS WAS SLEEPING IN A RECLINER CHAIR IN HIS ROOM. HE WAS FULLY RECLINED WITH LEG REST EXTENDED. HE WOKE UP TO THE BACK REST COLLAPSING IN STAGES. HE HEARD 3 POPS, THE BACK REST FELL IN STAGES WITH EACH POP. HE PARTIALLY SLID OUT OF THE CHAIR REPORTING THAT HE SLIGHTLY HIT HIS HEAD ON THE FLOOR OR THE LINEN CONTAINER. HE REPORTS NO INJURY. IT WAS DETERMINED THAT THE INTERIOR 2 BRACKETS ON THE BACKS OF RECLINERS THAT HOLD THE BACK TO THE SEAT WERE LOOSENING VIA LOOSE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912410 LAZY BOY RECLINER - MEDICAL GRAD CHAIR AND TABLE, MEDICAL KMN KNU, LLC DD1307U

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR